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Table of Content of ICH CTDModule 1: Administrative Information and Prescribing Information (1)Module 2: Common Technical Document Summaries (1)Module 3: Quality (5)Module 4: Nonclinical Study Reports (6)Module 5: Clinical Study Reports (8)Module 1: Administrative Information and Prescribing Information1.1 Table of Contents of the Submission Including Module 11.2 Documents Specific to Each Region (for example, application forms, prescribing information)Module 2: Common Technical Document Summaries2.1 Common Technical Document Table of Contents (Modules 2-5)2.2 CTD Introduction2.3 Quality Overall Summary(QOS)INTRODUCTION2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER)2.3.S.1 General Information (name, manufacturer)2.3.S.2 Manufacture (name, manufacturer)2.3.S.3 Characterisation (name, manufacturer)2.3.S.4 Control of Drug Substance (name, manufacturer)2.3.S.5 Reference Standards or Materials (name, manufacturer)2.3.S.6 Container Closure System (name, manufacturer)2.3.S.7 Stability (name, manufacturer).2.3.P DRUG PRODUCT (NAME, DOSAGE FORM)2.3.P.1 Description and Composition of the Drug Product (name, dosage form)2.3.P.2 Pharmaceutical Development (name, dosage form)2.3.P.3 Manufacture (name, dosage form)2.3.P.4 Control of Excipients (name, dosage form)2.3.P.5 Control of Drug Product (name, dosage form)2.3.P.6 Reference Standards or Materials (name, dosage form)2.3.P.7 Container Closure System (name, dosage form)2.3.P.8 Stability (name, dosage form)2.3.A APPENDICES2.3.A.1 Facilities and Equipment (name, manufacturer)2.3.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)2.3.A.3 Excipients2.3.R REGIONAL INFORMATION2.4 Nonclinical Overview2.4.1 Overview of the nonclinical testing strategy2.4.2 Pharmacology2.4.3 Pharmacokinetics2.4.4 Toxicology2.4.5 Integrated overview and conclusions2.4.6 List of literature references2.5 Clinical Overview2.5.1 Product Development Rationale2.5.2 Overview of Biopharmaceutics2.5.3 Overview of Clinical Pharmacology2.5.4 Overview of Efficacy2.5.5 Overview of Safety2.5.6 Benefits and Risks Conclusions2.5.7 Literature References2.6 Nonclinical Written and Tabulated Summaries PharmacologyPharmacokineticsToxicology2.6.1 Introduction2.6.2 Pharmacology Written Summary2.6.2.1 Brief Summary2.6.2.2 Primary Pharmacodynamics2.6.2.3 Secondary Pharmacodynamics2.6.2.4 Safety Pharmacology2.6.2.5 Pharmacodynamic Drug Interactions2.6.2.6 Discussion and Conclusions2.6.2.7 Tables and Figures2.6.3 Pharmacology Tabulated Summary (see Appendix B)2.6.3.1 Pharmacology: Overview2.6.3.2 Primary Pharmacodynamics*2.6.3.3 Secondary Pharmacodynamics*2.6.3.4 Safety Pharmacology2.6.3.5 Pharmacodynamic Drug Interactions*2.6.4 Pharmacokinetics Written Summary2.6.4.1 Brief Summary2.6.4.2 Methods of Analysis2.6.4.3 Absorption2.6.4.4 Distribution2.6.4.5 Metabolism (interspecies comparison)2.6.4.6 Excretion2.6.4.7 Pharmacokinetic Drug Interactions2.6.4.8 Other Pharmacokinetic Studies2.6.4.9 Discussion and Conclusions2.6.4.10 Tables and Figures2.6.5 Pharmacokinetics Tabulated Summary (see Appendix B)2.6.5.1 Pharmacokinetics: Overview2.6.5.2 Analytical Methods and Validation Reports*2.6.5.3 Pharmacokinetics: Absorption after a Single Dose2.6.5.4 Pharmacokinetics: Absorption after Repeated Doses2.6.5.5 Pharmacokinetics: Organ Distribution2.6.5.6 Pharmacokinetics: Plasma Protein Binding2.6.5.7 Pharmacokinetics: Study in Pregnant or Nursing Animals2.6.5.8 Pharmacokinetics: Other Distribution Study2.6.5.9 Pharmacokinetics: Metabolism In Vivo2.6.5.10 Pharmacokinetics: Metabolism In Vitro2.6.5.11 Pharmacokinetics: Possible Metabolic Pathways2.6.5.12 Pharmacokinetics: Induction/Inhibition of Drug-Metabolizing Enzymes2.6.5.13 Pharmacokinetics: Excretion2.6.5.14 Pharmacokinetics: Excretion into Bile2.6.5.15 Pharmacokinetics: Drug-Drug Interactions2.6.5.16 Pharmacokinetics: Other2.6.6 Toxicology Written Summary2.6.6.1 Brief Summary2.6.6.2 Single-Dose Toxicity2.6.6.3 Repeat-Dose Toxicity (including supportive toxicokinetics evaluation)2.6.6.4 Genotoxicity2.6.6.5 Carcinogenicity (including supportive toxicokinetics evaluations)2.6.6.6 Reproductive and Developmental Toxicity (including range-finding studies and supportive toxicokinetics evaluations)2.6.6.7 Local Tolerance2.6.6.8 Other Toxicity Studies (if available)2.6.6.9 Discussion and Conclusions2.6.6.10 Tables and Figures2.6.7 Toxicology Tabulated Summary (see Appendix B)2.6.7.1 Toxicology: Overview2.6.7.2 Toxicokinetics: Overview of Toxicokinetics Studies2.6.7.3 Toxicokinetics: Overview of Toxicokinetics Data2.6.7.4 Toxicology: Drug Substance2.6.7.5 Single-Dose Toxicity2.6.7.6 Repeat-Dose Toxicity: Non-Pivotal Studies2.6.7.7 Repeat-Dose Toxicity: Pivotal Studies2.6.7.8 Genotoxicity: In Vitro2.6.7.9 Genotoxicity: In Vivo2.6.7.10 Carcinogenicity2.6.7.11 Reproductive and Developmental Toxicity: Non-Pivotal Studies2.6.7.12 Reproductive and Developmental Toxicity –Fertility and Early Embryonic Development to Implantation (Pivotal)2.6.7.13 Reproductive and Developmental Toxicity –Effects on Embryo-Fetal Development (Pivotal)2.6.7.14 Reproductive and Developmental Toxicity –Effects on Pre- and Postnatal Development, Including Maternal Function (Pivotal)2.6.7.15 Studies in Juvenile Animalsa2.6.7.16 Local Tolerance2.6.7.17 Other Toxicity Studies2.7 Clinical Summary2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods2.7.1.1 Background and Overview2.7.1.2 Summary of Results of Individual Studies2.7.1.3 Comparison and Analyses of Results Across Studies2.7.1.4 Appendix2.7.2 Summary of Clinical Pharmacology Studies2.7.2.1 Background and Overview2.7.2.2 Summary of Results of Individual Studies2.7.2.3 Comparison and Analyses of Results Across Studies2.7.2.4 Special Studies2.7.2.5 Appendix2.7.3 Summary of Clinical Efficacy2.7.3.1 Background and Overview of Clinical Efficacy2.7.3.2 Summary of Results of Individual Studies2.7.3.3 Comparison and Analyses of Results Across Studies2.7.3.3.1 Study Populations2.7.3.3.2 Comparison of Efficacy Results of all Studies2.7.3.3.3 Comparison of Results in Sub-populations2.7.3.4 Analysis of Clinical Information Relevant to Dosing Recommendations2.7.3.5 Persistence of Efficacy and/or Tolerance Effects2.7.3.6 Appendix2.7.4 Summary of Clinical Safety2.7.4.1 Exposure to the Drug2.7.4.1.1 Overall Safety Evaluation Plan and Narratives of Safety Studies2.7.4.1.2 Overall Extent of Exposure2.7.4.1.3 Demographic and Other Characteristics of Study Population2.7.4.2 Adverse Events2.7.4.2.1 Analysis of Adverse Events2.7.4.2.2 Narratives2.7.4.3 Clinical Laboratory Evaluations2.7.4.4 Vital Signs, Physical Findings, and Other Observations Related to Safety2.7.4.5 Safety in Special Groups and Situations2.7.4.5.1 Intrinsic Factors2.7.4.5.2 Extrinsic Factors2.7.4.5.3 Drug Interactions2.7.4.5.4 Use in Pregnancy and Lactation2.7.4.5.5 Overdose2.7.4.5.6 Drug Abuse2.7.4.5.7 Withdrawal and Rebound2.7.4.5.8 Effects on Ability to Drive or Operate Machinery or Impairment of MentalAbility2.7.4.6 Post-marketing Data2.7.4.7 Appendix2.7.5 Literature References2.7.6 Synopses of Individual StudiesModule 3: Quality3.1 Table of Contents of Module 33.2 Body of Data(数据汇总)3.2.S DRUG SUBSTANCE (NAME, MANUFACTURER)3.2.S.1 General Information (name, manufacturer)3.2.S.1.1 Nomenclature (name, manufacturer)3.2.S.1.2 Structure (name, manufacturer)3.2.S.1.3 General Properties (name, manufacturer)3.2.S.2 Manufacture (name, manufacturer)3.2.S.2.1 Manufacturer(s) (name, manufacturer)3.2.S.2.2 Description of Manufacturing Process and Process Controls (name, manufacturer)3.2.S.2.3 Control of Materials (name, manufacturer)3.2.S.2.4 Controls of Critical Steps and Intermediates (name, manufacturer)3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer)3.2.S.2.6 Manufacturing Process Development (name, manufacturer)3.2.S.3 Characterisation (name, manufacturer)3.2.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer)3.2.S.3.2 Impurities (name, manufacturer)3.2.S.4 Control of Drug Substance (name, manufacturer)3.2.S.4.1 Specification (name, manufacturer)3.2.S.4.2 Analytical Procedures (name, manufacturer)3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer)3.2.S.4.4 Batch Analyses (name, manufacturer)3.2.S.4.5 Justification of Specification (name, manufacturer)3.2.S.5 Reference Standards or Materials (name, manufacturer)3.2.S.6 Container Closure System (name, manufacturer)3.2.S.7 Stability (name, manufacturer)3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer)3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment (name, manufacturer)3.2.S.7.3 Stability Data (name, manufacturer)3.2.P DRUG PRODUCT (NAME, DOSAGE FORM)3.2.P.1 Description and Composition of the Drug Product (name, dosage form)3.2.P.2 Pharmaceutical Development (name, dosage form)3.2.P.2.1 Components of the Drug Product (name, dosage form)3.2.P.2.1.1 Drug Substance (name, dosage form)3.2.P.2.1.2 Excipients (name, dosage form)3.2.P.2.2 Drug Product (name, dosage form)3.2.P.2.2.1 Formulation Development (name, dosage form)3.2.P.2.2.2 Overages (name, dosage form)3.2.P.2.2.3 Physicochemical and Biological Properties (name, dosage form)3.2.P.2.3 Manufacturing Process Development (name, dosage form)3.2.P.2.4 Container Closure System (name, dosage form)3.2.P.2.5 Microbiological Attributes (name, dosage form)3.2.P.2.6 Compatibility (name, dosage form)3.2.P.3 Manufacture (name, dosage form)3.2.P.3.1 Manufacturer(s) (name, dosage form)3.2.P.3.2 Batch Formula (name, dosage form)3.2.P.3.3 Description of Manufacturing Process and Process Controls (name, dosage form)3.2.P.3.4 Controls of Critical Steps and Intermediates (name, dosage form)3.2.P.3.5 Process Validation and/or Evaluation (name, dosage form)3.2.P.4 Control of Excipients (name, dosage form)3.2.P.4.1 Specifications (name, dosage form)3.2.P.4.2 Analytical Procedures (name, dosage form)3.2.P.4.3 Validation of Analytical Procedures (name, dosage form)3.2.P.4.4 Justification of Specifications (name, dosage form)3.2.P.4.5 Excipients of Human or Animal Origin (name, dosage form)3.2.P.4.6 Novel Excipients (name, dosage form)3.2.P.5 Control of Drug Product (name, dosage form)3.2.P.5.1 Specification(s) (name, dosage form)3.2.P.5.2 Analytical Procedures (name, dosage form)3.2.P.5.3 Validation of Analytical Procedures (name, dosage form)3.2.P.5.4 Batch Analyses (name, dosage form)3.2.P.5.5 Characterisation of Impurities (name, dosage form)3.2.P.5.6 Justification of Specification(s) (name, dosage form)3.2.P.6 Reference Standards or Materials (name, dosage form)3.2.P.7 Container Closure System (name, dosage form)3.2.P.8 Stability (name, dosage form)3.2.P.8.1 Stability Summary and Conclusion (name, dosage form)3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment (name, dosage form)3.2.P.8.3 Stability Data (name, dosage form)3.2.A APPENDICES3.2.A.1 Facilities and Equipment (name, manufacturer)3.2.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)3.2.A.3 Excipients3.2.R REGIONAL INFORMATION3.3 Literature ReferencesModule 4: Nonclinical Study Reports4.1 Table of Contents of Module 44.2 Study Reports(见正文)4.2.1 Pharmacology4.2.1.1 Primary Pharmacodynamics4.2.1.2 Secondary Pharmacodynamics4.2.1.3 Safety Pharmacology4.2.1.4 Pharmacodynamic Drug Interactions4.2.2 Pharmacokinetics4.2.2.1 Analytical Methods and Validation Reports (if separate reports are available)4.2.2.2 Absorption4.2.2.3 Distribution4.2.2.4 Metabolism4 2.2.5 Excretion4.2.2.6 Pharmacokinetic Drug Interactions (nonclinical)4.2.2.7 Other Pharmacokinetic Studies4.2.3 Toxicology4.2.3.1 Single-Dose Toxicity (in order by species, by route)4.2.3.2 Repeat-Dose Toxicity (in order by species, by route, by duration; including supportive toxicokinetics evaluations)4.2.3.3 Genotoxicity4.2.3.3.1 In vitro4.2.3.3.2 In vivo (including supportive toxicokinetics evaluations)4.2.3.4 Carcinogenicity (including supportive toxicokinetics evaluations)4.2.3.4.1 Long-term studies (in order by species; including range-finding studies that cannot appropriately be included under repeat-dose toxicity or pharmacokinetics)4.2.3.4.2 Short- or medium-term studies (including range-finding studies that cannot appropriately be included under repeat-dose toxicity or pharmacokinetics)4.2.3.4.3 Other studies4.2.3.5 Reproductive and Developmental Toxicity (including range-finding studies and supportive toxicokinetics evaluations) (If modified study designs are used, the following sub-headings should be modified accordingly.)4.2.3.5.1 Fertility and early embryonic development4.2.3.5.2 Embryo-fetal development4.2.3.5.3 Prenatal and postnatal development, including maternal function4.2.3.5.4 Studies in which the offspring (juvenile animals) are dosed and/or further evaluated.4.2.3.6 Local Tolerance4.2.3.7 Other Toxicity Studies (if available)4.2.3.7.1 Antigenicity4.2.3.7.2 Immunotoxicity4.2.3.7.3 Mechanistic studies (if not included elsewhere)4.2.3.7.4 Dependence4.2.3.7.5 Metabolites4.2.3.7.6 Impurities4.2.3.7.7 Other4.3 Literature ReferencesModule 5: Clinical Study Reports5.1 Table of Contents of Module 55.2 Tabular Listing of All Clinical Studies5.3 Clinical Study Reports5.3.1 Reports of Biopharmaceutic Studies5.3.1.1 Bioavailability (BA) Study Reports5.3.1.2 Comparative BA and Bioequivalence (BE) Study Reports5.3.1.3 In Vitro – In Vivo Correlation Study Reports5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies5.3.2 Reports of Studies Pertinent to Pharmacokinetics Using Human Biomaterials5.3.2.1 Plasma Protein Binding Study Reports5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies5.3.2.3 Reports of Studies Using Other Human Biomaterials5.3.3 Reports of Human Pharmacokinetic (PK) Studies5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports5.3.3.2 Patient PK and Initial Tolerability Study Reports5.3.3.3 Intrinsic Factor PK Study Reports5.3.3.4 Extrinsic Factor PK Study Reports5.3.3.5 Population PK Study Reports5.3.4 Reports of Human Pharmacodynamic (PD) Studies5.3.4.1 Healthy Subject PD and PK/PD Study Reports5.3.4.2 Patient PD and PK/PD Study Reports5.3.5 Reports of Efficacy and Safety Studies5.3.5.1 Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication5.3.5.2 Study Reports of Uncontrolled Clinical Studies5.3.5.3 Reports of Analyses of Data from More than One Study5.3.5.4 Other Study Reports5.3.6 Reports of Post-Marketing Experience5.3.7 Case Report Forms and Individual Patient Listings5.4 Literature ReferencesANNEX : Granularity Document参考ICH guidelines:M4E R1M4Q R1M4S R2。
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Supplemental Digital Content1. Methods to evaluate hepatic steatosisMRI is known to be the most accurate noninvasive method available to assess hepatic steatosis. Since only a portion of the patients in our study cohort underwent liver MRI, assessment of hepatic steatosis using MRI was only possible in these patients. Although it is less straightforward than the use of MRI or unenhanced CT, several studies1-3 have shown that hepatic steatosis can be evaluated using contrast-enhanced liver CT with moderate accuracy. The contrast-enhanced CT method had an advantage that it could be consistently applied to all patients of our study. One major limitation with contrast-enhanced CT, however, is the lack of truly generalized criteria to diagnose hepatic steatosis on contrast-enhanced CT, largely related to the variability caused by differences in contrast-enhancement methods. Therefore, we evaluated hepatic steatosis using contrast-enhanced CT for the entire study cohort and, in addition, using both MRI and contrast-enhanced CT in the patients who had undergone liver MRI. Given the limited accuracy of the contrast-enhanced CT method, we then estimated the prevalence of hepatic steatosis for the entire study cohort by referring to the comparative results of MRI and CT obtained in the subset of patients who had undergone MRI.The contrast-enhanced CT assessment of hepatic steatosis was according to quantitative attenuation measurement (in Hounsfield unit [HU]) of the liver and spleen using a standard region of interest (ROI) technique at a commercial picture archiving and communication system workstation (PetaVision; Asan Medical Center, Seoul, Korea). Mean liver and spleen attenuation was obtained by averaging three 1-cm2 square ROIs placed in each organ. The ROIs were placed in the central portion of the right hepatic lobe approximately at the level of hepatic hilum and in the central portion of the spleen at a similar level. Special care was taken to measure representative areas of hepatic and splenic parenchyma and to avoid any focal lesions or visible vessels. The ROI measurement was performed for all but two patients (861 patients). Two patients could not be evaluated due to the presence of numerous hepatic cysts and/or hamartomas and history of splenectomy. Hepatic steatosis was diagnosed on contrast-enhanced CT if the mean hepatic attenuation was lower than the mean splenic attenuation by greater than 20 HU.1, 2The MRI assessment of hepatic steatosis used a well-established dual-echo T1-weighted imaging method which compares hepatic signal intensity between in-phase and opposed-phase T1-weighted MR images. Hepatic signal intensity was measured using a standard ROI technique at a commercial picture archiving and communication system workstation (PetaVision; Asan Medical Center, Seoul, Korea). Three 1-cm2 square ROIs were placed in the central portion of the right hepatic lobe approximately at the level of hepatic hilum, with a particular care to measure representative areas and to avoid any focal lesions or visible vessels. The ROIs on the in-phase images were copied on to the opposed-phase images so that the corresponding ROIs were placed in the same location. Hepatic fat fraction was derived from the ROI measurements using the following equation: fat fraction = (S in- S ou t) ÷2S in⨯ 100 (%), where S in is the signal intensity on the in-phase image and S out is the signalintensity on the opposed-phage image. Hepatic steatosis was then diagnosed on MRI when the average hepatic fat fraction value of the three ROI locations was greater than 1.5%.4 2. Scan parameters for diffusion-weighted imaging of the liverDiffusion-weighted images were acquired using a respiratory-triggered, single-shot echo planar sequence with diffusion-weighted gradients (i.e., b-factors) of 0, 50, and 900 s/mm2 applied in three orthogonal directions. The other scan parameters for diffusion-weighted imaging were as follows: TR of approximately 3000-5000 ms; TE of 81 ms; slice section thickness of 6 mm; interslice gap of 1.2 mm; matrix of 192×162; number of signal averages of 5; use of parallel imaging technique with an acceleration factor of 2; fat saturation using the chemical shift-selective fat suppression technique; and rectangular field of view to fit.3. Patients whose benign focal hepatic lesions were determined by lesion resolutionCasenumber Age GenderPost-resolutionfollow-up length Additional imaging features1 F 55 29 months Size: <1 cmMRI: typical findings of a benign lesion*18F-FDG PET/CT: negative2 M 61 18 months Size: <1 cmMRI: typical findings of a benign lesion*18F-FDG PET/CT: negative3 F 67 12 months Size: <1 cmMRI: typical findings of a benign lesion*18F-FDG PET/CT: negative4 F 44 23 months Size: approximately 1.5 cmMRI: ill-define patchy abnormal parenchymal signalto suggest an inflammatory lesion5 M 65 23 months Size: approximately 1.3 cmMRI: ill-define patchy abnormal parenchymal signalto suggest an inflammatory lesion18F-FDG PET/CT: negative.6 M 56 29 months Size: approximately 1.2 cmMRI: ill-define patchy abnormal parenchymal signalto suggest an inflammatory lesion*Bright high signal on T2-weighted imaging, lack of enhancement on contrast-enhanced T1-weighted imaging, and lack of diffusion restriction.4. TSTC-liver-on-CT and negative-liver-on-CT patients who did not have adequate follow-upTSTC-liver-on-CT (n=31)‡Negative-liver-on-CT (n=24)‡Mean age (SD) 65.8 years (11.0) 67.5 years (12.6)GenderFemale 12 (39) 9 (38)Male 19 (61) 15 (63) Tumor locationColon20 (65) 7 (29) Rectum 11 (35) 17 (71) AJCC stage at presentation*Stage 0 3 (10) 3 (13) Stage 1 5 (16) 5 (21) Stage 2 5 (16) 4 (17) Stage 3 14 (45) 12 (50) Stage 4 4 (13) 0 (0)Serum CEA (ng/mL), median (range)†(n=28)2.4 (0.51-398)(n=19) 2.3 (0.48-148)Data are shown as the number of patients with percentages in parentheses (sum of which may not be 100% due to rounding), unless otherwise specified. When synchronous cancers were present, data are presented according to the most-advanced lesion.*According to AJCC 7th edition and excluding hepatic metastasis. Staging was classified according to pathologic TNM whenever applicable. In those patients treated nonsurgically, clinical staging information was used when pathologic staging data were lacking. The T and N stages of the rectal cancers that were treated using preoperative chemoradiation were determined at the pretreatment rectal MRI.†Number of patients with serum CEA data is provided in the parentheses.‡Reasons for the lack of adequate follow-up included transfer to another hospital or loss on follow-up (n=25), lack of imaging follow-up in patients who underwent curative endoscopic resection of early cancer (n=3), non-cancer-related death (n=2), or unspecified reasons (n=1) in TSTC-liver-on-CT group and were transfer to another hospital or loss on follow-up (n=17), curative endoscopic resection of early cancer (n=6), or unspecified reasons (n=1) in negative-liver-on-CT group.5. Patients with hepatic metastases that manifested as TSTC lesionsCase numberAge(years) Gender Tumor locationAJCC stage at presentation*Serum CEA(ng/mL)T N M Overall1 56 M Rectum 3 1 0 3B 1.22 54 M Rectum3 1 0 3B 1.73 61 F Rectum4 2 1 4B 534 79 F Ascending colon 3 1 0 3B 1.15 68 M Rectum 3 1 0 3B 3.0*According to AJCC 7th edition and excluding hepatic metastasis. Staging was classified according to pathologic TNM whenever applicable. In those patients treated nonsurgically, clinical staging information was used when pathologic staging data were lacking. The T and N stages of the rectal cancers that were treated using preoperative chemoradiation were determined at the pretreatment rectal MRI.6. References for Supplemental Digital Content1) Kim DY, Park SH, Lee SS, et al. Contrast-enhanced computed tomography for thediagnosis of fatty liver: prospective study with same-day biopsy used as the referencestandard. Eur Radiol. 2010;20:359-366.2) Jacobs JE, Birnbaum BA, Shapiro MA, et al. Diagnostic criteria for fatty infiltrationof the liver on contrast-enhanced helical CT. AJR Am J Roentgenol. 1998;171:659-664.3) Lawrence DA, Oliva IB, Israel GM. Detection of hepatic steatosis on contrast-enhanced CT images: diagnostic accuracy of identification of areas of presumed focal fatty sparing. AJR Am J Roentgenol. 2012;199:44-47.4) van Werven JR, Marsman HA, Nederveen AJ, et al. Assessment of hepatic steatosis inpatients undergoing liver resection: comparison of US, CT, T1-weighted dual-echoMR imaging, and point-resolved 1H MR spectroscopy. Radiology. 2010;256:159-168.。
Software RequirementsSpecificationfor<Project>软件需求规格说明Version 1.0 approvedPrepared by <author><organization><date created>Translated by Hiphonejohn Contact Me , E-mail:hiphonejohn@Table of Contents目录Table of Contents目录 (iii)Revision History版本历史 (iii)1.Introduction 引言 (1)1.1Purpose 目的 (1)1.2Document Conventions 文档约定 (1)1.3Intended Audience and Reading Suggestions使用人群和阅读建议 (1)1.4Product Scope 产品范围 (1)1.5References参考文献 (1)2.Overall Description 总体描述 (2)2.1Product Perspective产品愿景 (2)2.2Product Functions产品功能 (2)2.3User Classes and Characteristics用户类型和特征 (2)2.4Operating Environment操作环境 (3)2.5Design and Implementation Constraints设计和实现约束 (3)2.6User Documentation用户文档 (3)2.7Assumptions and Dependencies假设和依赖 (3)3.External Interface Requirements外部接口需求 (4)3.1User Interfaces用户接口 (4)3.2Hardware Interfaces硬件接口 (4)3.3Software Interfaces软件接口 (4)3.4Communications Interfaces通信接口 (4)4.System Features系统特征 (5)4.1System Feature 1系统特征1 (5)4.2System Feature 2 (and so on)系统特征2,如上。
Operating ManualAgilent TechnologiesElectronic Load MainframesModels 6050A and 6051AFor instruments with Serial Numbers:Agilent 6050A-2908A-00101 and AboveAgilent 6051A-2927A-00101 and AboveAgilent Part No. 5959-3368 Printed in USA: October, 1997 Microfiche Part No. 5959-3369 Reprinted April, 2000CERTIFICATIONAgilent Technologies certifies that this product met its published specifications at time of shipment from the factory. Agilent Technologies further certifies that its calibration measurements are traceable to the United States National Bureau of Standards, to the extent allowed by the Bureau’s calibration facility, and to the calibration facilities of other International Standards Organization members.WARRANTYThis Agilent Technologies hardware product is warranted against defects in material and workmanship for a period of three years from date of delivery. Agilent Technologies software and firmware products, which are designated by Agilent Technologies for use with a hardware product and when properly installed on that hardware product, are warranted not to fail to execute their programming instructions due to defects in material and workmanship for a period of 90 days from date of delivery. During the warranty period Agilent Technologies will, at its option, either repair or replace products which prove to be defective. Agilent Technologies does not warrant that the operation of the software, firmware, or hardware shall be uninterrupted or error free.For warranty service, with the exception of warranty options, this product must be returned to a service facility designated by Agilent Technologies Customer shall prepay shipping charges by (and shall pay all duty and taxes) for products returned to Agilent Technologies for warranty service. Except for products returned to Customer from another country, Agilent Technologies shall pay for return of products to Customer.Warranty services outside the country of initial purchase are included in Agilent Technologies product price, only if Customer pays Agilent Technologies international prices (defined as destination local currency price, or U.S. or Geneva Export price).If Agilent Technologies is unable, within a reasonable time to repair or replace any product to condition as warranted, the Customer shall be entitled to a refund of the purchase price upon return of the product to Agilent TechnologiesLIMITATION OF WARRANTYThe foregoing warranty shall not apply to defects resulting from improper or inadequate maintenance by the Customer, Customer-supplied software or interfacing, unauthorized modification or misuse, operation outside of the environmental specifications for the product, or improper site preparation and maintenance. NO OTHER WARRANTY IS EXPRESSED OR IMPLIED. AGILENT TECHNOLOGIES SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.EXCLUSIVE REMEDIESTHE REMEDIES PROVIDED HEREIN ARE THE CUSTOMER’S SOLE AND EXCLUSIVE REMEDIES. AGILENT TECHNOLOGIES SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, WHETHER BASED ON CONTRACT, TORT, OR ANY OTHER LEGAL THEORY.ASSISTANCEThe above statements apply only to the standard product warranty. Warranty options, extended support contracts, product maintenance agreements and customer assistance agreements are also available. Contact your nearest Agilent Technologies Sales and Service office for further information on Agilent Technologies’ full line of Support Programs.23SAFETY SUMMARYThe following general safety precautions must be observed during all phases of operation, service, and repair of this instrument. Failure to comply with these precautions or with specific warnings elsewhere in this manual violates safety standards of design, manufacture, and intended use of the instrument. Agilent Technologies assumes no liability for the customer’s failure to comply with these requirements.BEFORE APPLYING POWER.Verify that the product is set to match the available line voltage and the correct fuse is installed.GROUND THE INSTRUMENT.This product is a Safety Class 1 instrument (provided with a protective earth terminal). To minimize shock hazard, the instrument chassis and cabinet must be connected to an electrical ground. The instrument must be connected to the ac power supply mains through a three-conductor power cable, with the third wire firmly connected to an electrical ground (safety ground) at the power outlet. For instruments designed to be hard-wired to the ac power lines (supply mains), connect the protective earth terminal to a protective conductor before any other connection is made. Any interruption of the protective (grounding) conductor or disconnection of the protective earth terminal will cause a potential shock hazard that could result in personal injury. If the instrument is to be energized via an external autotransformer for voltage reduction, be certain that the autotransformer common terminal is connected to the neutral (earthed pole) of the ac power lines (supply mains).FUSES.Only fuses with the required rated current, voltage, and specified type (normal blow, time delay, etc.) should be used. Do not use repaired fuses or short circuited fuseholders. To do so could cause a shock or fire hazard.DO NOT OPERATE IN AN EXPLOSIVE ATMOSPHERE.Do not operate the instrument in the presence of flammable gases or fumes.KEEP AWAY FROM LIVE CIRCUITS.Operating personnel must not remove instrument covers. Component replacement and internal adjustments must be made by qualified service personnel. Do not replace components with power cable connected. Under certain conditions, dangerous voltages may exist even with the power cable removed. To avoid injuries, always disconnect power, discharge circuits and remove external voltage sources before touching components.DO NOT SERVICE OR ADJUST ALONE.Do not attempt internal service or adjustment unless another person, capable of rendering first aid and resuscitation, is present.DO NOT EXCEED INPUT RATINGS.This instrument may be equipped with a line filter to reduce electromagnetic interference and must be connected to a properly grounded receptacle to minimize electric shock hazard. Operation at line voltages or frequencies in excess of those stated on the data plate may cause leakage currents in excess of 5.0 mA peak.SAFETY SYMBOLS.Instruction manual symbol: the product will be marked with this symbol when it is necessary for the user to refer to theinstruction manual (refer to Table of Contents) .Indicates hazardous voltages.Indicate earth (ground) terminal.The WARNING sign denotes a hazard. It calls attention to a procedure, practice, or the like, which, if not correctlyperformed or adhered to, could result in personal injury. Do not proceed beyond a WARNING sign until theindicated conditions are fully understood and met.The CAUTION sign denotes a hazard. It calls attention to an operating procedure, or the like, which, if not correctlyperformed or adhered to, could result in damage to or destruction of part or all of the product. Do not proceedbeyond a CAUTION sign until the indicated conditions are fully understood and met.DO NOT SUBSTITUTE PARTS OR MODIFY INSTRUMENT.Because of the danger of introducing additional hazards, do not install substitute parts or perform any unauthorized modification to the instrument. Return the instrument to an Agilent Technologies Sales and Service Office for service and repair to ensure that safety features are maintained.Instruments which appear damaged or defective should be made inoperative and secured against unintended operation until they can berepaired by qualified service personnel.4SAFETY SUMMARY (continued)GENERALAny LEDs used in this product are Class 1 LEDs as per IEC 825-l.ENVIRONMENTAL CONDITIONSThis instruments is intended for indoor use in an installation category II, pollution degree 2 environment. It is designed to operate at a maximum relative humidity of 95% and at altitudes of up to 2000 meters. Refer to the specifications tables for the ac mains voltage requirements and ambient operating temperature range.SAFETY SYMBOL DEFINITIONSSymbol Description Symbol DescriptionAlternating currentBoth direct and alternating currentThree-phase alternating currentEarth (ground) terminalProtective earth (ground) terminalFrame or chassis terminalDECLARATION OF CONFORMITYaccording to ISO/IEC Guide 22 and EN 45014Manufacturer’s Name: Agilent Technologies, Inc.Manufacturer’s Address: New Jersey Division150 Green Pond RoadRockaway, NJ 07866 U.S.A.declares that the productProduct Name:Load mainframe and modulesModel Number(s):Agilent 6050A, 6051A mainframes with modulesAgilent 60501A/B, 60502A/B, 60503A/B, 60504A/B, 60507A/Bconform(s) to the following Product Specifications:Safety:IEC 348:1978 / HD401 S1:19811EMC:CISPR 11:1990 / EN 55011:1991 Group 1, Class BIEC 801-2:1991 / EN 50082-1:19924kV CD, 8 kV ADIEC 801-3:1984 / EN 50082-1:1992 3 V/mIEC 801-4:1988 / EN 50082-1:19920.5 kV Sig. Lines, 1 kV Power Lines Supplementary Information:The product herewith complies with the requirements of the Low Voltage Directive 73/23/EEC and the EMC Directive 89/336/EEC and carries the CE-marking accordingly.Note 1: The product family was introduced prior to 12/93--------------------------------------------------------New Jersey, January 1997Bruce Krueger / Quality Manager European Contact: Your local Agilent Technologies Sales and Service Office or Agilent Technologies GmbH,Department TRE, Herrenberger Strasse 130, D-71034 Boeblingen (FAX:+49-7031-14-3143)Printing HistoryThe current edition of this guide is indicated below. Reprints of this guide containing minor corrections and updates may have the same printing date. New editions are identified by a new printing date and, in some cases, by a new part number.A new edition incorporates all new or corrected material since the previous edition. Changes to the guide occurring between editions are covered by change sheets shipped with the guide. Also, if the serial number prefix of your power module is higher than those listed on the title page of this guide, then it may or may not include a change sheet. That is because even though the higher serial prefix indicates a design change, that change may not affect the content of the guide. Edition 3May, 1993© Copyright 1993 Agilent Technologies, Inc. .....................October, 1997Update.........April, 2000This document contains proprietary information protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced, or translated into another language without the prior consent of Agilent Technologies The information contained in this document is subject to change without notice.56If you are a first-time user, start with this manual, paying particular attention to Chapter 2. After installation (Chapter 3),read Chapter 4 to learn front-panel operation. Programming users should then read Chapter 5 before going to theProgramming Reference Guide. Experienced programming users will probably refer only to the Programming Reference Guide.Agilent 6050A/6051A Operating ManualAgilent Part No. 5959-3368(this manual)SpecificationsSystem OverviewInstallation ProceduresFront-Panel Operation RemoteProgramming IntroductionCalibration ProceduresModule-Specific PagesAgilent Models 60501A/B, 60502A/B, 60503A/B,60504A/B, 60507BSpecificationsProgramming RangesFactory Default SettingsCalibration InformationAgilent Technologies Electronic Load FamilyProgramming Reference GuideAgilent Part No. 06060-90005Introduction to HPSLIntroduction to ProgrammingLanguage DictionaryStatus ReportingAgilent 6050A/605L4 Service ManualModule Service Manuals* Supplied with Agilent 6050A/6051A Electronic Load Mainframe.** Supplied with individual load modules.*** Available for purchase. Supplied with instrument if ordered as Option 910.Table of Contents1.General InformationWhat’s in this Manual (11)Options (11)Safety Requirements (12)Specifications (12)2.Operation OverviewIntroduction (15)Front Panel Description (16)Remote Programming (16)Local/Remote Control (16)Extended Power Operation (17)Programmable Features (17)Modes of Operation (17)Constant Current CC (Mode) (18)Ranges (18)Immediate Current Level (18)Triggered Current Level (18)Transient Current Level (19)Software Current Limit (19)Slew Rate (19)Constant Resistance (CR) Mode (19)Ranges (20)Immediate Resistance Level (20)Triggered Resistance Level (20)Transient Resistance Level (20)Slew Rate (20)Constant Voltage (CV) Mode (20)Range (20)Immediate Voltage Level (21)Triggered Voltage Level (21)Transient Voltage Level (21)Slew Rate (21)Transient Operation (21)Continuous Transient Operation (22)Pulsed Transient Operation (22)Toggled Transient Operation (23)Triggered Operation (24)Slew Rate and Minimum Transition Time (25)Input Current, Voltage, and Power Measurement (26)Short On/Off (26)Input On/off (27)Saving and Recalling Settings (27)Reading Remote Programming Errors (27)Status Reporting (28)Protection Features (28)Resetting Latched Protection (28)Overvoltage (29)7Overcurrent (29)Overpower (29)Overtemperature (30)Reverse Voltage (30)Control Connector (30)Remote Sensing (30)Monitor Outputs (30)External Programming Input (31)Fault (31)Port On/Off (31)3.InstallationIntroduction (33)Inspection (33)Installing The Modules (33)Procedure (34)Channel Number (35)Installing The Mainframes (35)Cooling (36)Rack Mounting (36)Turn-On Checkout (36)Changing Line Voltage (37)Turn-On/Selftest (38)Power Test (39)Controller Connection (39)GPIB Address (40)Rear Panel Connectors and Switches (40)Input Binding Posts (40)Control Connector (41)Sense Switch (41)Trigger Connector (43)Application Connections (43)Wiring Considerations (43)Local Sense Connections (44)Remote Sense Connections (44)Parallel Connections (44)Zero-Volt Loading Connections (45)4.Local OperationIntroduction (49)Local Control Overview (52)Using The CHAN Keys (53)Selecting the Channel (54)Identifying the Selected Channel (54)Using The Function Keys (54)Turning the Input On/Off (54)Setting the Mode of Operation (56)Setting CC Values (56)Programming Ranges (56)8Examples (56)Setting CR Values (57)Programming Ranges (57)Examples (58)Setting CV Values (59)Programming Range (59)Examples (59)Transient Operation (60)Shorting the Input (61)Resetting Latched Protection (61)Using The System Keys (62)Setting the GPIB Address (62)Displaying Error Codes (62)Saving and Recalling Settings (62)Changing "Wake-up" Settings (63)Recalling the Factory Default Values (63)5.Remote OperationIntroduction (65)Enter/Output Statements (65)GPIB Address (65)Sending A Remote Command (66)Selecting A Channel (66)Getting Data Back (66)Remote Programming Commands (67)CC Mode Example (68)CV Mode Example (68)CR Mode Example (71)Continuous Transient Operation Example (71)Pulsed Transient Operation Example (72)Synchronous Toggled Transient Operation Example (72)6.CalibrationIntroduction (75)Equipment Required (75)Calibration Commands (76)Calibration Flowcharts (77)Example Programs (77)A.Considerations for Operating in Constant Resistance Mode (91)Index (93)Agilent Sales and Support Offices (97)91 General InformationWhat’s In This ManualThis manual applies to both the Agilent6050A and Agilent 6051A Electronic Load mainframes. The two mainframes are functionally identical, but the Agilent 6051A is a half-rack width unit, with only two slots for load modules. Most of the information given in this manual applies to both mainframes. Where differences occur, information specific just to the Agilent 6051A is given in parentheses following information that applies only to the Agilent 6050A, for example: ... a total of 1800(600) watts...This chapter contains specifications that apply to the Agilent 6050A and Agilent 6051A Electronic Load mainframes, as well as information concerning options and safety requirements. The remaining chapters in this manual contain instructions for installing, operating, programming, and calibrating the Electronic Load as followsChapter 2 "Operation Overview":describes all of the Electronic Load’s functions and briefly describes how they can becontrolled locally at the front panel and/or remotely via a GPIB controller.Chapter 3 "Installation":provides instructions for installing load modules in the mainframe, controller andapplication connections, and turn-on checkout procedures.Chapter 4 "Local Operation":describes in detail how to operate the Electronic Load at the front panel.Chapter 5 "Remote Operation":provides an introduction to remote programming.Chapter 6 "Calibration":contains calibration procedures for the Electronic Load and gives sample calibrationprograms. Yearly calibration intervals are recommended.Specifications and other information pertinent to a specific load module are given in the module-specific pages provided with each load module.OptionsUnless one of the following line voltage options is ordered, the unit is shipped from the factory set for 120 Vac, 48-63 Hz ac input power. If Option 100, 220, or 240 is ordered, the unit will be factory set for the appropriate line voltage.For information about changing the line voltage setting, see "Turn-On Checkout" in Chapter 3.100: Input Power, 100 Vac, 48-63 Hz220: Input Power, 220 Vac, 48-63 Hz240: Input Power, 240 Vac, 48-63 HzAdditional options are:800:One rack mount kit for two half-rack units side by side (Agilent 6051A only)*908:One rack mount kit*909: One rack mount kit with handles (Agilent 6050A only)*910:One service manual with extra Operating Manual and Programming Reference Guide*Support rails are required for Options 800, 908, and 909.General Information 11Safety RequirementsThis product is a Safety Class 1 instrument, which means that it is provided with a protective earth ground terminal. This terminal must be connected to an ac source that has a 3-wire ground receptacle. Review the instrument rear panel and this manual for safety markings and instructions before operating the instrument. Refer to the Safety Summary page at the beginning of this manual for a summary of general safety information. Specific safety information is located at appropriate places in this manual.The Electronic Load is designed to comply with the following safety and environmental requirements:• IEC 348-Safety requirements for electronic measuring apparatus.• CSA 22.2 No. 231-Electronic instruments and scientific apparatus for special use and applications.• UL 1244-Electrical and electronic measuring and testing equipment.S pecificationsT able 1-1 lists the specifications and supplemental characteristics for the Agilent 6050A/6051A Electronic Load mainframe. All specifications apply over an operating range of 0 to +55°C for the mainframe. Specifications are guaranteed through the warranty of the product. Supplemental characteristics are type-tested or typical values based on a product sample and, while representative, are not guaranteed for all instruments.T able 1-1. Agilent 6050A/6051A Specifications and Supplemental CharacteristicsS pecifications:A C Input:T hree internal switches permit operation from 100, 120, 220, or 240 Vac lines.A mplitude:-13% to +6% nominal line voltageF requency:48 to 63 HzS upplemental Characteristics:A C Input:F use: The ac input is protected by internal fuses.M aximum VA: 635G PIB Programming Command Processing Time (Time required for a GPIB command processed by the Electronic Load): 70 milliseconds (typical)G PIB Interface Capabilities:S H1, AH1, T6, L4, SR1, RLI, DT1, DC1T rigger Input:V lo = 0.9 V maximum at Ilo = -1 mAV hi = 3.15 V minimum (pull-up resistor on input)T rigger Input:V lo = 0.72 V maximum at Ilo = 1 mAV hi = 4.4 V minimum at Ilo = -20 µA12 General InformationT able 1-1. Agilent 6050A/6051A Specifications and Supplemental Characteristics (continued)W eight:N et (mainframe only):Agilent 6050A, 9.5 kg (21 lb.)Agilent 6051A, 5.5 kg (12 lb.)S hipping:Agilent 6050A, 14 kg (31 lb.)Agilent 6051A, 7.5 kg (17 lb.)D imensions:W idth:Agilent 6050A, 425.5 mm (16.75 in.)Agilent 6051A, 213 mm (8.4 in.)H eight:178 mm (7 in.), add 10 mm (0.4 in.) for removable feetD epth:625 mm (24.6 in.), including input connectors on modulesGeneral Information 132 O peration OverviewI ntroductionT he Agilent 6050A and Agilent 6051A Multiple Input Electronic Load Mainframes are used for design, manufacturing, and evaluation of dc power supplies, batteries, and power components. Other applications include use as a power circuit breaker or crowbar, high-current function or pulse generator, fuel-cell and photovoltaic cell test, and de-energizing superconducting magnets.T he mainframe contains six (two) slots for load modules. Load modules occupy either 1 or 2 slots, depending on the power rating of the module. The mainframe can dissipate up to 300 watts per slot, to a total of 1800 (600) watts for a fully loaded mainframe. An individual module may have either 1 or 2 channels, each of which has its own channel number. Each module contains its own input connectors. The mainframe contains a processor, GPIB connector and interface circuits, trigger circuits, front-panel keypad and display, and other circuits common to all the load modules.E ach module can operate independently in constant current (CC) mode, constant voltage (CV) mode , or constant resistance (CR) mode. In addition, each input can be turned on or off (open circuit) or short circuited.F eatures include built-in GPIB interface and built-in pulse generator, both standard. Pulse mode allows dynamic testing of power supplies and components, without giving the device under test time to heat up. The flexible pulse mode provides six triggering methods, allowing synchronization with a wide variety of events. A Save/Recall feature allows you to save up to 7 complete instrument setups, one of which can be saved in non-volatile memory so that it is recalled automatically at power-on. Also standard is GPIB readback of actual input voltage and current, and extensive protection and status reporting capability.T he mainframe contains two (one) cooling fans whose speed automatically increases or decreases as the module temperatures rise and fall. This feature reduces overall noise level because the fans do not run at maximum speed at all times.T he input power rating curve for each module is shown in the module-specific pages. See the extended power paragraphs in this section for a description of the power rating curves. Note that regardless of a module’s power rating, input current is derated linearly from 2 volts down to 0 volts.E ach load module can be individually controlled either via GPIB or locally via the front panel. Once a channel is selected or addressed, all subsequent commands go to that channel until another channel is selected or addressed. Operation of all models is similar, regardless of power ratings. Therefore, the operating instructions given in this manual are generic, and apply to all modules. The module-specific pages provided with each module include specifications and other information pertinent just to a particular model. Some examples described here may use values that are not appropriate for your module, but the example is valid. Some descriptions refer to ranges, limits, full-scale values, and similar terms (for example, low range and high range). Refer to the module-specific pages provided with each module for the actual values.P rograms written for the Agilent 6060 series of single Electronic Loads can be used with the multiple loads, easing program development for applications using various members of the Agilent Electronic Load family. (Triggering via the ac line frequency or the load’s internal timer is available only in the multiple load mainframe.)I f your application requires a greater power or current capacity than one module can provide, load modules can be connected in parallel in CC or CR mode.O peration Overview 15F ront Panel DescriptionT he front panel includes a 12-character alphanumeric display, 11 status indicators, and four groups of keypads. Ordinarily the alphanumeric display shows the number of the channel presently under front-panel control, and the input voltage and current of that channel. By using thekey. If you change channels via the front panel, any fault information will be displayed first for the new channel. Then you can key through the display in the normal sequence. The alphanumeric display also shows what function is being performed when you use the keypads.T he display also includes 11 annunciators that point to the 11 status labels printed on the front panel. The ConstantC urrent, Constant Resistance, Constant Voltage, Transient, and Unregulated status annunciators are specific to the channel displayed. The Protection, Error, Shift, Remote, Address, and Service ReQuest status annunciators are channel independent.F our of the keys perform two functions, with the alternative function labeled in blue above the key. The alternative function is selected by first pressing the blue (shift) key, which turns on the Shift annunciator and enables the alternative function.N ote that the front-panel display operates independently from the GPIB CHANNEL command. In other words, you can select a channel locally (front panel) for which the display will show the input voltage and current, and the controller can subsequently send commands to other channels without changing the channel being displayed.R emote ProgrammingC ommands sent to the Electronic Load via GPIB are decoded by the mainframe microprocessor, which detects syntax and range errors. The mainframe processor also prescales data sent to the modules, and maintains status registers for each module. Three commands have aliases for compatibility with other HPSL instruments. MODE can also be called FUNCtion, INPut can also be called OUTPut, and CHANnel can also be called INSTrument. OUTPut and INSTrument would typically be used if you want your program to refer to the load modules in terms of the device or instrument under test. Be careful if using INSTrument for CHANnel in systems that have more than one Electronic Load mainframe; someone looking at the listing in the future may be misled.L ocal/Remote ControlL ocal (front panel) control is in effect immediately after power is applied. The front panel keypad and display allow manual control of each individual module when the Electronic Load is used in bench test applications. Remote (computer) control goes into effect (front panel Rmt annunciator is on) as soon as the mainframe receives a command via the GPIB. A built-in GPIB interface and HPSL compatible commands allow control and readback of all functions when the Electronic Load is used in computer controlled applications.W ith remote control in effect, only the computer can control the Electronic Load; the front panel keypad has no effect. You can, however, still use the front panel display to view the input voltage and current readings. You can return the ElectronicLoad to local control from remote control by pressing16 Operation Overview。
content的用法和短语例句【导语】早上记住content的短语,下午熟悉它的用法,晚上就掌握它的例句。
以下是给大家带来content的用法和短语及参考例句,以供参阅。
【篇一】content的用法大全content的用法1:content的基本意思有三:第一,可表示“所容纳之物,所含之物”,指某一物体中所含的具体东西; 第二,表示一本书或文章中所包含的“内容”,可以是具体的内容,也可以是抽象的内容; 第三,表示某一容器的“容量”或某一物质在另一物质中的“含量”。
content的用法2:content表示“内容”时用单数和复数的意思不同,用复数表示具体的内容,而用单数则表示与形式相对应比较抽象的“要旨,内含”; 在表示“含量,容量”时只能用单数; 表示“所容纳之物,所含之物”时多用复数。
content的用法3:content的基本意思是“使满足,使满意”,指做一些让人高兴的事情,以使他人感到满足,其宾语多为人。
content的用法4:content主要用作及物动词,后接名词或代词作宾语。
content的用法5:content常用于content oneself with结构,表示“满足于…”。
content的用法6:content作形容词时意思是“愿意和渴望得到满足的”,这种满足的程度不一定是完全彻底的,但人已不必再为此或为彼而心烦意乱了。
content的用法7:content后可接with引起的短语或动词不定式,表示“能够这样(做)已经知足了”,有时还可接that从句。
content的用法8:content在句中主要用作表语。
content的用法9:content没有比较级和级。
【篇二】content的常用短语用作动词 (v.)content with (v.+prep.)用作名词 (n.)to one’s heart’s content用作形容词 (adj.)content with【篇三】content的用法例句1. There are reports of widespread dis-content in the capital.有报道称首都弥漫着不满的情绪。
table of contents 例子Table of Contents Example:Chapter 1: Introduction1.1 Background1.2 Purpose of the Study1.3 Research Questions1.4 Significance of the StudyChapter 2: Literature Review2.1 Theoretical Framework2.2 Previous Studies2.3 Gaps in the Literature2.4 Conceptual FrameworkChapter 3: Methodology3.1 Research Design3.2 Data Collection Methods3.3 Sampling Technique3.4 Data AnalysisChapter 4: Results4.1 Presentation of Findings4.2 Analysis of Results4.3 Discussion of FindingsChapter 5: Conclusion5.1 Summary of the Study5.2 Implications of the Study5.3 Limitations and Recommendations for Future Research ReferencesAppendices附录A: 调查问卷附录B: 原始数据以上是一个使用中文的目录示例,共包含五个章节,每个章节下分为几个小节进行细分。
章节1介绍研究的背景、目的、研究问题和研究的重要性。
章节2进行文献综述,包括理论框架、先前研究、文献的不足之处以及概念框架。
章节3详细描述了研究的方法论,包括研究设计、数据收集方法、抽样技术和数据分析。
章节4呈现了研究结果,并进行了结果分析和讨论。
©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .GIAC Security EssentialsPractical Assignment Version 1.4bOnlineSubmitted by: Tan Koon Yaw©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .Table of ContentABSTRACT..........................................................................................................1 1. INTRODUCTION. (1)2. INITIAL RESPONSE (2)3. EVIDENCE GATHERING..............................................................................3 4. PROTECTING THE VOLATILE INFORMATION..........................................3 5. CREATING A RESPONSE TOOLKIT.. (4)6. GATHERING THE EVIDENCE (7)7. SCRIPTING THE INITIAL RESPONSE (15)8. IDENTIFICATION OF FOOTPRINTS (15)9. WHAT’S NEXT?..........................................................................................16 10.WRAPPING UP (16)REFERENCES (18)APPENDIX A (19)©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .Windows Responder’s GuideAbstractWhen a system encounters an incident, there is a need to handle the case properly to gather evidence and investigate the cause. Initial response is the stage where preliminary information is gathered to determine whether there is any breach of security and the possible causes if any. This paper provides the first responder guide to handle incident occur on a Windows platform system.In this paper, we will discuss what are the issues one needs to consider during the initial response stage. There are critical evidence that need to be protected and gathered during the initial response stage. We will hence discuss what are the tools that can be used to gather the necessary evidence and how to collect them appropriately. Finally, we will explore areas that one needs to look out for during the investigation on the evidence collected. 1. IntroductionWhen a system encounters an incident, the common reaction among most people will be to panic and jump straight into the system to find out the cause and hopefully try to get it back to normal working condition as soon as possible. Such knee-jerk reactions is especially so for systems supporting critical business operations. However, such actions may tamper with the evidence and even lead to a lost of information causing potential implications. This is especially critical if the recourse actions involve legal proceedings. Hence it is very important to establish a set of proper and systematic procedures to preserve all evidence during this critical initial response stage.Not every incident will lead to a full investigation or legal proceeding. However, in the event when a security breach has taken place, proper handling of the system is necessary. However, one should always bear in mind that different incidents might require different procedures to resolve.In most cases, not all systems can afford the downtime to carry a fullinvestigation before knowing the most possible cause. Initial response is the stage of preliminary information gathering to determine the probable causes and the next appropriate response. Responders should be equipped with the right knowledge on how and what information to collect without disrupting the services. During the initial response, it is also critical to capture the volatile evidence on the live system before they are lost.This paper will cover the initial response focusing on the windows platform, how and what evidence should be collected and analyzed quickly. We will begin the discussion on what is initial response, what are the potential issues need to be©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .considered, what to do and what not to do during the stage of initial response. To carry out the initial response successfully, the responder needs to prepare a set of tools to gather the evidence. We will list out some of the essential tools that a responder should be equipped and run through how and what evidence should be collected. This paper will not cover the forensic investigative analysis process. However, areas to look out for footprints of intrusion on the system will be discussed. 2. Initial ResponseInitial response is the stage where preliminary information is gathered todetermine whether there is any breach of security, and if so, to determine the possible breach and assess the potential impact. This will allow one to determine what is the next course of action, whether to let the system continues its operation or arrange for immediate isolation for a full investigation.During the initial response stage, the following questions (Who, What, When, Where, How) should be asked: • Who found the incident? • How was the incident discovered? • When did the incident occur? • What was the level of damage? • Where was the attack initiated? • What techniques were being used to compromise the system?There should be a well-documented policy and procedures on how different types of incidents should be handled. It is also important to understand thepolicies and response posture. The level of success to solve an incident does not depend only on the ability to uncover evidence from the system but also the ability to follow proper methodology during the incident response and evidence gathering stage.When one suspects a system is compromised, the natural question is to ask whether to bring the system offline, power off the system or let it remains. For a compromised system, do you intend to collect evidence and trace the attacker or just patch the system and life goes on? There is no right answer to this. It really depends on the organization business needs and response plan. For example, when one suspects the attacker is still on the system, you may not want to alert him/her by pulling the system offline immediately, but let the system remains and continue to monitor the his/her activities before taking appropriate actions.However, for system that contains sensitive information, there may be a need to pull the system offline immediately before incurring further damage.©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .3. Evidence GatheringElectronic media is easily manipulated, thus a responder needs to be carefulwhen handling evidence. The basic principles to keep in mind when gathering the evidence is to perform as little operations on the system as possible and maintain a detailed documentation on every single steps on what have been done to the system.Majority of the security incidents do not lead to civil or criminal proceedings. However, it is to the best interest of the organization to treat the incidents with the mindset that every action you take during incident response may later lead to legal proceeding or one day under the scrutiny of individuals who desire to discredit your techniques, testimony or basic finding skills.Maintaining a chain of custody is important. Chain of custody establishes arecord of who handle the evidence, how the evidence is handled and the integrity of the evidence is maintained.When you begin to collect the evidence, record what you have done and the general findings in a notebook together with the date and time. Use a tape recorder if necessary. Note that the system that you are working on could be rootkited.Keep in mind that there are things to avoid doing on the system: • Writing to the original media • Killing any processes • Meddling the timestamp • Using untrusted tools • Meddling the system (reboot, patch, update, reconfigure the system). 4. Protecting the Volatile InformationWhen the system is required to undergo the computer forensic process, it is necessary to shutdown the system in order to make bit-level image of the drive. There are discussions on how system should be shutdown, and we are not going to cover this in details here. However, by shutting down the system, a great deal of information will be lost. These are the volatile information, which include the running processes, network connection and memory content. It is therefore essential to capture the volatile information on the live system before they are lost.©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .The order of volatility is as follows: • Registers, cache contents • Memory contents • State of network connections • State of running processes • Contents of file system and hard drives • Contents of removable and backup mediaFor the first four content, the information are lost or modified if the system is shutdown or rebooted.Some of the volatile evidence that are important to gather are: • System date and time • Current running and active processes • Current network connections • Current open ports • Applications that listening on the open sockets • Current logon usersSuch volatile evidence is important, as it will provide the critical first hand information, which may make or break a case. In some cases, some hackers may have tools that run in memory. Gathering such evidence is therefore necessary as part of the initial response procedure. 5. Creating a Response ToolkitPreserving evidence and ensuring those evidence that you gather is correct is very important. There is a need to ensure the programs and tools that one uses to collect the evidence are trusted. Burning them into a CD-ROM media will be ideal to carry them around when responding to incidents. The responder should always be equipped with the necessary programs beforehand. This will shorten the response time and enable a more successful response effort.There are many tools available that can be used to gather evidence from the system. Below is a list of tools that you should minimally be equipped with. There could be more depending how much you wish to carry out prior to bit-level imaging of the media. The important is to harvest the volatile information first. Those residing on the media could still be retrieved during the forensic analysis on the media image.You need to ensure the tools that you used will not alter any data or timestamp of files in the system. It is therefore important to create a response disk that has allthe dependencies covered. The utility, filemon, could be used to determine the files being accessed and affected by each of the tool used.Below is the set of response tools you should prepare:© S A N SI n s t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .6. Gathering the EvidenceA critical question to ask someone when you encounter a live system is whether the system has been rebooted. It will be great news if the answer is no, but a yes reply is usually not a surprise.Albeit the system has been rebooted and caused some vital information to be lost, it is still a good practice to carry out the initial response steps to gather the evidence prior to shutting down the system, as you will never know there could still be some other footprints around.Step One: Open a Trusted Command ShellThe first step is to ensure all the tools are run from a trusted command shell.Initiate a command shell from the Start Menu. Run the trusted command prompt from the trusted tools from the CD you have prepared.All subsequent commands should then be run over this trusted shell.©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .Key fingerprint = AF19 FA27 2F94 998D FDB5 DE3D F8B5 06E4 A169 4E46 Step Two: Prepare the Collection SystemRemember that you should not write the evidence collected to the original media. A simple way is to write the data to a floppy disk. However, some of the evidence collected may exceed the disk space of the floppy disk. One simple way is to pipe the data over the network to your responder’s system. To do this, we could use the popular known “TCP/IP Swiss Army Knife” tool, netcat, to perform the job.The process of setting up the netcat is first by setting up the netcat listener on your responder’s system.D:\>nc -l -p 55555 >> evidence.txtThe above command open a listening port on your responder’s system and redirect anything received to evidence.txt. The switch -l indicates listening mode. The listener will close the socket when it receives data. To allow the listener to continue to listen harder after the first data is captured, use the -L switch instead. Thus, you can choose whether to create a new file for each command or appending all evidence gathered into one single file by using the appropriate switch. The switch -p allows you to select the port for the listener. You could choose any other port.When the listener is ready, you can start to pipe the evidence to the responder’s system by executing the following (assuming E Drive is the CD ROM Drive):E:\>nc <IP address of responder’s system> <port> -e <command>ORE:\<command> | nc <IP address of responder’s system> <port>For example, if you want to pipe the directory listing to the responder’s system (with IP address 10.1.2.3), you execute:E:\> nc 10.1.2.3 55555 -e dirORE:\dir | nc 10.1.2.3 55555Note that the evidence pipes through netcat is in clear. If you prefer to encrypt the channel (for example, you suspect there is a sniffer on the network), you can use cryptcat. Cryptcat is the standard netcat enhanced with twofish encryption. It is used in the same way as netcat. Note that the secret is hardcoded to be "metallica" (use the -k option to change this key).u te 2003,A ut ho rr et a in sf u l l ri g h t s .Figure 1: Using netcat to collect evidenceStep Three: Collect Volatile EvidenceNow you can start running your toolkit to collect the volatile evidence.The necessary evidence to collect is: • Basic system information • Running processes • Open sockets • Network connections • Network shares • Network usersThe system date and time should be recorded before and after collecting the evidence.D:\>nc –l –p 55555 >> evidence.txt E:\>nc 10.1.2.3 55555 –e <command> E:\><command> | nc 10.1.2.3 55555o rr et a in sf u l l ri g h t s .Some of the evidence gathered may seem normal but when all the evidence are collected, they provide a good picture of the system. From there, one can trace the normal and unusual processes, connections and files occurring in the system.Step Four: Collect Pertinent LogsAfter gather the volatile information, the next thing is to gather the pertinent logs. While this information is not considered to be volatile and could be retrieved during the forensic investigation, getting these information will still be helpful to get the first hand knowledge of the cause. Note that bit-level image of the media could take a while and during this period, investigation can be started on these logs first.The pertinent logs to gather are: • Registry • Events logs • Relevant application logs©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .Note that an attacker can make use of the NTFS stream to hide files. For example, the following will allow the attacker to hide the file, hack_file.exe, in web.log.C:\> cp hack_file.exe web.log:hack_file.exeThe file size of web.log will not change. To identify stream file, use the streams command.To obtain the stream file, you just need to reverse the process:C:\> cp web.log:hack_file.exe hack_file.exe©S e 2003,A ut ho rr et a in sf ul l ri g h t s .Stream file can be executed by START command:C:\> start web.log:hack_file.exeEvent logs and other application logs are next to collect. They could be piped over to the responder’s system using the cat utility. The default locations are as follows: After the files are captured into the responder’s system, you should make a md5sum on the files to ensure the integrity of the files are not tampered when carry out subsequent investigation.Step Five: Perform additional network surveillanceWhere possible, it is good to monitor closely any connection to the system subsequently, especially if you suspect the attacker might return. Running a sniffer program on another system to monitor the network activities on that suspected system would be good.©S AN SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .7. Scripting the Initial ResponseThe commands used to gather the evidence can be written in a batch file. This will make the job of the responder easier and at the same time avoid mistyping the command. A simple way to create a script is to create a text file and give a .bat extension to it. This will give us a very neat way to collect evidence from the system. For example, we could key in the following as a single text file with file name ir.bat:8. Identification of FootprintsYou have now collected: • Basic system information • Running processes • Open sockets • Network connections • Network shares • Network users • Pertinent logsThe next step is to identify the footprints. During the review, one should look out for the following: • Check for hidden or unusual files • Check for unusual processes and open sockets • Check for unusual application requests • Examine any jobs running©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .• Analyze trust relationship • Check for suspicious accounts • Determine the patch level of the systemWhenever there is any suspicious observation, take note of the event andtimestamp. Correlate the event with other logs based on related files, processes, relationship, keywords and timestamp. The timestamp will also be useful tocorrelate with external logs such as the logs from firewall and intrusion detection system. Any suspected events should not be left out.If one is analyzing IIS records, note that it uses UTC time. This is supposed to help to synchronize when running servers in multiple time zones. Windows calculates UTC time by offsetting the value of the system clock with the system time zone. Take note of this when you correlate the entries of the IIS logs with timestamp of other logs.The Registry provides a good audit trail: • Find software installed in the past • Determine security posture of the machine • Determine DLL Trojan and startup programs • Determine Most Recently Used (MRU) Files information 9. What’s Next?Based on initial response finding, one should be able to determine the possible cause of the security breach and decide the next course of action whether to: • Perform a full bit-level imaging for full investigation; • Call the law enforcer; or • Get the system back to normal (reinstall, patch and harden the system).For bit-level disk image, there are tools out that that could perform an excellent job. Encase and SafeBack are two of the commercial tools that you could consider for image acquisition and restoration, data extraction, and computer forensic analysis. Another tool that you can consider is dd, which is free. dd is a utility that comes with most Unix platform. Now it has ported to Windows platform as well and you can get it at /.10. Wrapping UpIn the event of any incident, having a proper initial response plan and procedure is important to ensure the evidence gathered is intact and at the same time do not tamper the evidence as far as possible. Volatile information is critical to©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .protect and ensure they are collected first before they are lost. Sometimes such information may make or break a case.By having a good preparation to response to any security incidents will save a lot of time and effort in handling cases. Planning ahead is necessary for initial response. Never rush to handle an incident without any preparation.Having said all these, the next step after a good preparation is practice. The actions taken during the stage of initial response is critical. Do not wait for an incident to occur before you start to kick in your established plan, checklist and toolkit. Remember practice makes perfect.©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .ReferencesH. Carvey, “Win2K First Responder’s Guide”, 5 September 2002, URL: /infocus/1624Jamie Morris, “Forensics on the Windows Platform, Part One”, 28 January 2003, URL: /infocus/1661Stephen Barish, “Windows Forensics: A Case Study, Part One”, 31 December 2002, URL: /infocus/1653Stephen Barish, “Windows Forensics - A Case Study: Part Two”, 5 March 2003, URL: /infocus/1672Mark Burnett, “Maintaining Credible IIS Log Files”, 13 November 2002, URL: /infocus/1639Norman Haase, “Computer Forensics: Introduction to Incident Response and Investigation of Windows NT/2000”, 4 December 2001, URL: /rr/incident/comp_forensics3.phpLori Willer, “Computer Forensics”, 4 May 2001, URL: /rr/incident/comp_forensics2.phpKelvin Mandia and Chris Prosise, “Incident Response: Investigating Computer Crime”, Osborne/McGraw-Hill, July 2001, ISBN: 0-07-213182-9//////©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .Appendix AFigure A-1: envFigure A-2: psinfo©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g ht s .Figure A-3: psuptimeFigure A-4: net startFigure A-5: pslist©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .Figure A-6: pulistFigure A-7: psservice©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .Figure A-8: listdllsFigure A-9: fport©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .Figure A-10: Last Access TimeFigure A-11: Last Modification Time©S A N SI ns t i tu te 2003,A ut ho rr et a in sf u l l ri g h t s .Figure A-12: Last Create TimeFigure A-13: hfind。