1.每一种药物都有其固有的药理作用特点。如果给药剂量，给药次数，给药途径恰当，大多数病人可以产生预期的药理效应。但对具体的病人来说，药理效应可有一定的甚至是非常明显的差异。病人体质，药物质量，病原微生物，以及各种环境条件都可能影响药物作用。它们可以使药物效应减弱或增强。产生个体差异的主要原因是药物的吸收，分布，生物转化和排泄的差异。要保证每个病人都能达到最大疗效、最小不良反应的治疗目的，单纯根据药理作用选药和用药显然是不够的，还必须掌握影响各种药物的因素，结合病人具体情况，决定适当的治疗方案，并在用药过程中不断根据变化及时适当地作出调整，直至病人痊愈。Each medicine has its inherent the pharmacological function characteristics. If the administration dosage, to therapy, delivery methods appropriate, most patients can produce the desired pharmacological effect. But to specific patients for, pharmacological effect can have certain even very clear differences. Patients constitution, drug quality, pathogenic microbes, and various environmental conditions may affect drug interactions. They can make the effects of drugs increase or decrease. Produce individual difference is the main reason of the drug absorption, distribution, biological transformation and excretion of differences. To ensure that every patient can achieve maximum efficacy, minimum adverse reaction of therapeutic purposes, pure according to choose medicine and pharmacology drug it is not enough, still must master the influence of the factors of different drugs, patients with specific situations, to determine the appropriate treatment, and in the process of drug use in time according to change constantly adjust properly, until the patient recover.
2、构成的解决方案
干燥固体颗粒从这些正是构成方案准备注射熊的标题形式(药品注射。由于这些剂型构成的保健医生使用,测试和标准制定有关管理的解决方案是不包括在个人专著在固体或液体无菌干精矿。然而,在保证质量的兴趣注射制剂作为他们实际上是管理,以下无损检测提供了展示了合适的解决方案时,他们构成准备之前使用。
CONSTITUTED SOLUTIONS
Dry solids from which constituted solutions are prepared for injection bear titles of the form [DRUG] for Injection. Since these dosage forms are constituted at the time of use by the health care practitioner, tests and standards pertaining to the solution as constituted for administration are not included in the individual monographs on sterile dry solids or liquid concentrates. However, in the interest of assuring the quality of injection preparations as they are actually administered, the following nondestructive tests are provided for demonstrating the suitability of constituted solutions when they are prepared just prior to use.
3.当事人cosponsoring他们对这次会议re-affirmed增加国际协调,旨在保证良好的质量、安全、有效的药物开发,注册于上海最有效率和最经济的方式。这些活动均以消费者的利益和公共卫生,防止不必要的重复的人类临床试验,并尽量避免妨碍使用动物试验没有妥协的规章的义务的安全性和有效性。The Parties cosponsoring this Conference re-affirmed their commitment to increased international harmonisation, aimed at ensuring that good quality, safe and effective medicines are developed and registered in the most efficient and cost-effective manner. These activities are pursued in the interest of the consumer and public health, to prevent unnecessary duplication of clinical trials in humans and to minimise the use of animal testing without compromising the regulatory obligations of safety and effectiveness。
4.我很高兴的宣布它将与认证标准开发组织(sdo)关联起来,以便利用发展我e-Inititatives 技术标准。这个决定遵循一系列的讨论结果在提高效率的过程,开始我督导委员会会议于
2005年5月。另外,可能产生的标准都将会被吸收更多的non-ICH从而提高国家和组织对全球标准。我标准在全球范围内扩大我实现我的标准的视觉的future-development更有效率的过程和均匀性要求增加药物开发全球没有妥协的质量、安全和疗效标准预计由医护人员和病人。ICH is pleased to announce that it will collaborate with accredited Standards Development Organizations (SDOs) to leverage the development of technical standards for ICH e-Inititatives. This decision follows the outcome of a series of discussions on improving the efficiency of the ICH process that started at the Steering Committee meeting in May, 2005. Additionally it is likely that the resulting standards would be taken up by many more non-ICH countries and organizations thereby elevating ICH standards to global standards. Expanding ICH standards globally would fulfill ICH’s vision of the future—development of more efficient processes and increased uniformity of drug development requirements globally without compromising the quality, safety, and efficacy standards expected by practitioners and patients.
5.在美国所有的新药必须要得到联邦食品与药品管理局的批准才能上市。所有药物都会有潜在的不良反应，所以，只有当某种药物的益处大于其风险时，它才有可能被批准上市。但是，对新药审批的检查需要很长时间，因此联邦食品与药品管理局在1987年出台一项规定，允许在一些有价值的试验期间药物用于危重病人。同时他们也警告说若不经有经验的临床医生评估病情而随便使用这种尚未被批准的药物，对这些患者反而有害无益。总之，即使是实验期间药品也必须符合某个益处风险比例才可试用。In the United States all the drug must to get the federal food and drug administration approval to market. All drugs can have potential adverse effects, therefore, only when a certain drug benefits outweigh the risks, it is likely to be approved on the market. But, the examination and approval of new drug inspection needs a long time, so the federal food and drug administration in 1987 issued a regulation, allowed in some valuable during the tests of drugs for critically ill patient. At the same time they also warned that if not through experienced clinical doctors estimate to use this illness and has not yet been approved drugs, the patients but harmful. All in all, even during the drug also must comply with a good risk proportion to the trial.
6.本世纪60 年代开始，美国国会赋予食品与药物管理局监督处方药广告的权力。但有关药品及生物制品广告及宣传的规定在数量上很有限。书面规定的短缺使FDA 能够随时改变其政策及行为而不必对公众说明情况。制药业、广告商及推广商对这种状况深表关注。他们认为在目前这种竞争激烈及信息密集的环境下，制定有关他们所关心的问题的法规应该经过正式的行政程序，并且这个程序应给予任何公司和个人对此项规定作出评论及请求改变的机会。目前的情况是这些公司必须去遵守一些不成文的政策，而且这些政策的实施也没有公开，这就使整个制药业都处于不利状态。因此，他们急切期望曰叭在药物广告及宣传的规定及实施上有所改进。Since the's, the United States congress granted the food and drug administration supervision and prescription drug advertising power. But about the drugs and biological products advertising and publicity of provisions in the number is very limited. Stipulated in writing the shortage of FDA can change its policies and actions to the public and don't have to explain. The pharmaceutical industry, advertisers and promoter are deeply concerned about the situation. They think that in the current competitive information and dense environment, for they are concerned with the problems and regulations should be after formal administrative procedures, and the program should be given any companies and individuals to make a comment about this paragraph and request opportunity to change. The current situation is these companies have to keep some unwritten policies, and the implementation of these policies and no public, this makes the whole industry is in a bad state.
Therefore, they were eager expectation yue in drug advertising and publicity seems the provisions on the implementation and improvement.
7.药品和生物制品是与人民生活密切相关的特殊商品，对这些产品的严格管理是对人民健康负责的表现。现阶段在我国，越来越多的人选择去药房买药来治疗一些小病，如发烧、感冒等。这些消费者的选择往往是那些从药品广告，特别是电视广告中听来的药品。为确保这些广告不会使消费者误入歧途或自开药方，它们被要求加入“请按医生处方购买”字样。但事实上，众多的消费者仍然忽视这个忠告，因而一方面，制药业、广告商及市场开拓者需遵循有关法规，在其广告及宣传资料中应详细说明该产品的优点及风险，以及所有相关信息，不论是对其有利还是不利的。另一方面，有关部门也应重视对消费者的教育，教育他们要充分认识到药品广告的局限性，以便能够判断什么是他们最佳的选择。
Pharmaceutical and biological products is closely related to people's life and special goods, for these products strict management is responsible for the performance of the people's health. At present in our country, more and more people choose to go to the pharmacy to buy medicines to treat some ailment, such as fever, colds, etc. These consumer choice is often those who from drug advertising, especially television ads to drug listened. To ensure that these ads consumers will not be put astray or from a prescription, they were asked to join "please press a doctor's prescription to buy," the words. But in fact, many consumers still ignore the advice, so on the one hand, the pharmaceutical industry, advertisers and market the blazers have to follow the relevant laws and regulations, in its advertising and publicity material specified in the product and the advantages of risk, and all relevant information, whether for its positive or negative. On the other hand, the relevant departments have attention should be paid to the consumer education, education they should fully understand the limitations of the drug advertising, in order to be able to tell what is their best choice.
8.在过去的30 年间，制药业经历了巨大的变化，其中的一些变化是因为技术的进步而带来的结果，而另外一些变化则是因为组织结构上的变化而引起的。不管怎么说，与从前相比，现在的研究和发展环境是大大地改善了。
首先是技术上的进步给科研提供了更多的便利：今天的科研人员拥有他们的前辈在30 年前所没有的技术装备。这些新技术使30 年前已“过时”的随机筛选法又获新生。
其次是生物技术以及制药业中与之相关部门的出现。这使得本行业中出现了很多从事生物技术的小公司。而这些小公司的出现又在很大程度上改变了制药业的构成。将来的情况是大的制药公司将主要致力于研制开发市场潜力巨大的产品，小公司将作为大公司的补充，开发那些需求量虽小但却能发挥其技术优势的产品。
In the past 30 years, the pharmaceutical industry has experienced great changes, some of these changes due to the progress of technology and will bring results, and some other change it is because of the change of organizational structure and cause. Anyway, compared with the former, now of the research and development environment is greatly improved.
First are the technical progress to scientific research to provide a more convenient: today's scientific research personnel have their predecessors in 30 years ago have no technical equipment. These new technology makes 30 years ago has "out of date" random screening method and normal life.
Second is the biological technology and the pharmaceutical industry and the related
departments in there. This makes the industry there are many biological technology in a small company. And these small company's appearance and to a great extent changed the structure of the pharmaceutical industry. The future is big pharmaceutical companies will mainly devotes to research and development the market has great potential products, small company will as a big company of supplement, the demand for development is small but it can play its technical advantage of the products.
9.基础研究是科学进步的基础，也是一切工业发展的动力，但由于基础研究往往是为追求真理本身而进行的（conducted in the pursuit of truth for its own sake ) ，不能象应用研究那样马上带来直接的经济效益，很多机构不愿意为其投资。即使在美国这样的发达国家，每年用于基础研究的资金也只占全部科研资金的7 % ，因此，不难想象在众多的发展中国家情况还要糟得多。制药业的情况或多或少也是一样的。制药公司愿意为研制某种新药投资而不愿为基础研究投资，因为他们希望在短时间内获利。但可喜的是，本行业在近年来也已意识到这是一种短视的做法。例如，人们已经意识到，如果不真正掌握癌症的致病原因，那末所有的抗癌药物只能是缓解剂而非治疗剂。从长远来看，谁在基础研究上有所突破，谁才能最终获利。这也许会成为制药业投资基础研究的动机吧。
The basic research is the foundation of scientific progress, is all the power for the development of the industry, but due to the basic research is often seek truth itself for the (conducted in the pursuit of truth for its own sake), can not be like application research that immediately bring direct economic benefit, many institutions are reluctant to for their investment. Even in developed countries such as the U.S., every year for the basic research of the capital account for just 7% of all research funds, therefore, it is not difficult to imagine in many of the developing countries worse situation. The pharmaceutical industry situation more or less is the same. Pharmaceutical companies are willing to develop a new drug for investment rather than for the basic research investment, because they want to profit in a short time. But the good news is this industry in recent years have already aware that this is a short-sighted approach. For example, people have realized, if not master the causes of cancer, then all of the cancer drugs can only is to alleviate the agent and not therapeutic agent. In the long run, who has achieved in basic research, who can eventually profit. This may be the motive of the pharmaceutical industry investment basis?
应当由有资格的人员定期进行培训，至少应当包括员工所从事的特定操作和与其职能有关的GMP。培训记录应当保存，并且应定期对培训进行评估。By a qualified personnel shall be regular training shall at least include the employees engaged in the specific operating and its function of the GMP. Training records shall be kept, and should be regularly for the training for the evaluation.
中间体或原料药生产和控制的顾问应当有足够的学历，受训和经验，能胜任所承担的工作。Intermediate or API production and control of the consultants shall have enough education, training and experience, can be competent for the job.
实验室区域/操作通常应当与生产区隔离。有些实验室区域，特别是用于中间控制的，可以位于生产区内，只要生产工艺操作对实验室测量的准确性没有负面影响，而且实验室及
其操作对生产过程，或中间体，或原料药也没有负面影响。Laboratory area/operation and production areas shall be usually isolation. Some laboratory area, especially used in the middle control, located in production area can be, as long as production process operation on the measuring accuracy of the laboratory no negative effects, and laboratory and its operation on the production process, or intermediates, or an API and no negative effects.
剧毒的非药用物质，如除草剂，杀虫剂的任何生产活动（包括称重，研磨或包装）都不应当使用生产原料药的厂房和/或设施。这类剧毒非药用物质的处理和贮存都应当与原料药分开。The medicinal material not poisonous, such as herbicides, pesticide any production activities (including weighing, grinding or packaging) should use active pharmaceutical ingredients (apis) workshop and/or facilities. This kind of medicinal substance poisonous handling and storage should be separated with API. 进入和流出厂房以及临近区域的污水，垃圾和其他废物（如生产中的固态，液态或气态的副产物），应当安全，及时，卫生地处理。废物的容器和/或管道应当显著地标明。
Into and out of the area near the factory and sewage, trash and other waste (such as the production of the solid, liquid or gaseous by-products), shall be safe, timely, health to deal with. Waste containers and/or pipe shall be as significant.
世界医学会制定赫尔辛基宣言,作为报表的伦理原则,以期指导医师及医学研究人员在对涉及人类的科目。涉及人体试验之医学研究包括研究人类的材料或可辨认的数据。The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.
医师之职责,促进和保障人民的健康。医生的知识和良知应奉献于此一使命完成。It is the duty of the physician to promote and safeguard the health of the people. The physician's knowledge and conscience are dedicated to the fulfillment of this duty.
《独立宣言》的日内瓦的世界医学会使医生说:“我的病人的健康将是我的第一次考虑,“国际代码医学伦理学的声明:“医生应当只在病人的利益提供医疗护理可能的作用削弱了生理和心理状
态的病人。”The Declaration of Geneva of the World Medical Association binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient."
医学之进步奠基于科学研究,而此研究终究必须有部份仰赖其他有关人体试验。Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects.
在医学研究中对人类研究对象,考虑相关的人类主体的幸福应该优先于科学与社会的利益。In medical research on human subjects, considerations related to the well-being of the human
subject should take precedence over the interests of science and society.
医学研究的主要目的是改善有关人体试验的预防、诊断和治疗的程序和成因之瞭解及致病机转的疾病。即使是最好的行之有效的预防、诊断及治疗之方法,通过研究应不断地挑战为他们的有效性、效率、可得性和质量。The primary purpose of medical research involving human subjects is to improve prophylactic, diagnostic and therapeutic procedures and the understanding of the aetiology and pathogenesis of disease. Even the best proven prophylactic, diagnostic, and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality.
在当前的医疗实践和医学研究中,大多数的预防、诊断及治疗程序都涉及风险和负担。In current medical practice and in medical research, most prophylactic, diagnostic and therapeutic procedures involve risks and burdens.
医学研究伦理标准必须发扬尊重所有的人类和保护他们的健康和权利。一些研究人口脆弱,需要特别保护。特定的需求和医学弱势经济必须被认可。也需要特别注意那些不能给自己或拒绝同意,那些将会受到答应被胁迫,对于那些将不利于个人从研究和那些为谁研究结合护理。Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care.
研究人员应该知道之伦理、法律和法规的要求,为研究人类主体在他们自己的国家以及适用的国际需求。没有全国性的伦理、法律、法规的要求应该被允许减少或消除任何保护人类受试者中所述的这一宣言。Research Investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration.
医师之职责医学研究中保护生命、健康、个人隐私和尊严受试验者之。It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject.
有关人体试验的医疗研究必须符合公认的科学原则,全面了解的基础上的科学文献,其他相关的信息来源,及适当的实验室,并在适当的情况下,动物实验。Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and on adequate laboratory and, where appropriate, animal experimentation.
都必须谨慎实施过程中可能影响环境之研究,动物福利所用于研究必须要被尊重。Appropriate caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.
每一个设计、性能指标进行人体实验程序应该明确制定实验协议。本议定书应提交的考虑、意见、指导,并在适当的地方,一个特别指定审批伦理审查委员会,必须独立的调查员,赞助或者其它类型的不良影响。这个独立委员会应是符合法律、法规的国家进行实验研究。该委员会有权监督正在进行的试验。研究者有义务向委员会提供监测信息,尤其是任何严重不良事件。研究者还应向委员会审查,有关资金、赞助商、制度背景,其他潜在的利益冲突、奖励的科目。The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed. The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects.
试验计画书应该包含一个相关伦理考量的声明表明,应符合本宣言所揭橥之原则。The research protocol should always contain a statement of the ethical considerations involved and should indicate that there is compliance with the principles enunciated in this Declaration.
有关人体试验的医疗研究应该进行人才,只有科学的监督下,临床医学主管人。人类的责任主体必须总要休息资格的人员和医学无法休息主题的研究,即使这个课题给予同意。Medical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given consent.
每一个有关人体试验的医疗研究计划,事前须审慎评估可能的风险、责任、以及可预见的利益相比,对受试验者或其他人。这并不妨碍健康志愿者参与的医学研究。所有研究的设计应该公开的方式。Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others. This does not preclude the participation of healthy volunteers in medical research. The design of all studies should be publicly available.
医生应避免从事有关人体试验的研究计划,除非他们有信心的风险已充份评估可以很好地管理。医生应停止其研究发现,如果风险超过潜在的利益或如果有确凿证据积极有益的结果。Physicians should abstain from engaging in research projects involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians should cease any investigation if the risks are found to outweigh the potential benefits or if there is conclusive proof of positive and beneficial results.
涉及人体试验之医学研究才可以进行如果在研究目的之重要性大于其固有的风险负担的话题。这是特别重要的是当人体健康志愿者。Medical research involving human subjects should only be conducted if the importance of the objective outweighs the inherent risks and burdens
to the subject. This is especially important when the human subjects are healthy volunteers.
医学研究唯有被的族群可能的研究才有其执行成果中获益的研究。Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.
受试者必须是志愿参加,并告知参与该项研究计划。The subjects must be volunteers and informed participants in the research project.
在治疗病人,在证明预防、诊断和治疗的方法不存在或已经无效的,医生,与患者知情同意,必须自由地使用新的或新的预防、诊断和治疗措施,如果在医生的判断,它提供了希望拯救生命,
还健康或减轻痛苦。如果可能,这些措施应该使研究对象,旨在评估他们的安全性和有效性。在所有病例中,新信息应该被记录,并在适当的情况下,出版了。其他有关规定申报应该被执行。In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, these measures should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new information should be recorded and, where appropriate, published. The other relevant guidelines of this Declaration should be followed.
研究结果表明,每一个患者进入书房应该是保证获得最优秀的证明的预防、诊断和治疗的方法被研究。医生应充分告知病患,那些方面的医疗照护与研究。病人拒绝参加研究必须不影响医患关系。At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study. The physician should fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study must never interfere with the patient-physician relationship.
医师可以结合医学研究与医疗照护,只有不同的研究有潜在的预防、诊断或治疗的价值。当医学研究结合医疗照护时,额外的准则来保护这些患者作为研究对象。收益、风险、责任和效果的一种新方法需要被测试目前最佳的预防、诊断和治疗方法。这并不排除使用安慰剂或不治疗,还没有证明研究预防、诊断或治疗的方法。The physician may combine medical research with medical care, only to the extent that the research is justified by its potential prophylactic, diagnostic or therapeutic value. When medical research is combined with medical care, additional standards apply to protect the patients who are research subjects. The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.
研究对象的权利保护其完整性必须得到尊重。应采取各种措施尊重隐私主体、保密的病人的信息以及减少负面影响研究的主体的身心健全及人格的主题。在任何研究人类,每个潜在的主体必须充分了解的目的、方法、资金来源,任何可能的利益冲突、制度归属的研究员,预期效益和潜在风险的研究和不安可能需要。主体的权利应该被告知要禁戒参与学习或撤回同意参加任何时间,而不会报复。在确保这个课题的理解信息,医师应最终获得主体的freely-given知情同意,最好是书面的同意。如果无法取得书面同意,撰写必须正式同意记载和证据。
The right of research subjects to safeguard their integrity must always be respected. Every
precaution should be taken to respect the privacy of the subject, the confidentiality of the patient's information and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject. In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject's freely-given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.
在获取知情同意研究项目医师应特别注意主题有依赖关系,医师或被胁迫同意。在那种情况下,知情同意应该得到了消息灵通的医生,他没有参与调查和谁是完全独立于这一关系。为研究对象法律无能,身体上的还是精神上无法答应或者是一个法律上无能的未成年人,研究者必须得到通知
其法定代理人同意依照可适用的法律。这些团体不应被包括在研究是非常必要的,除非研究促进大众健康,代表和本研究代替不用于合法的主管人。When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship with the physician or may consent under duress. In that case the informed consent should be obtained by a well-informed physician who is not engaged in the investigation and who is completely independent of this relationship. For a research subject who is legally incompetent, physically or mentally incapable of giving consent or is a legally incompetent minor, the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law. These groups should not be included in research unless the research is necessary to promote the health of the population represented and this research cannot instead be performed on legally competent persons.
当一个主题被视为无法律无能,如一个未成年的孩子,会给同意对参与研究的决定时,研究人员必须获得批准,除了其法定代理人同意。研究从谁不是个人春意取得同意,包括代理radvance同意,只有当他应该做的身心状况,防止受试同意书是一个必要特征的研究人口。具体的原因,包括研究对象的情况下,也会使他们变得无法告知应规定审核和批准实验协议的审查委员会。该方案要声明同意留在研究应尽快获得从个人还是一个经合法授权的代理。When a subject deemed legally incompetent, such as a minor child, is able to give assent to decisions about participation in research, the investigator must obtain that assent in addition to the consent of the legally authorized representative. Research on individuals from whom it is not ossible to obtain consent, including proxy radvance consent, should be done only if he physical/mental condition that prevents obtaining informed consent is a necessary characteristic of the research population. The specific reasons for involving research subjects with a condition that renders them unable to give informed consent should be stated in the experimental protocol for consideration and approval of the review committee. The protocol should state that consent to remain in the research should be obtained as soon as possible from the individual or a legally authorized surrogate.
两个作者和出版商有道德责任。在发表的研究成果,研究人员必须保存结果的精度。消极和积极的结果就会出版或其它公众开放。资金来源、制度背景和任何可能的利益冲突应该定义在出版发行。实验报告不符合原则躺在此声明不应该接受发表。Both authors and publishers have ethical obligations. In publication of the results of research, the investigators are obliged to preserve
the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available. Sources of funding, institutional affiliations and any possible conflicts of interest should be declared in the publication. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.
多媒体技术教程》（第三版）习题解答 第1章绪论 1．多媒体信息系统和多媒体计算机有什么不同？在概念上应如何看待两者之间的关系？多媒体信息系统是新一代高度集成的、功能强大的、智能化的计算机信息系统，它是提供多媒体信息、辅助人们对环境进行控制和决策的系统，是基于计算机、通信网络等现代化的工具和手段，服务于管理领域的信息处理系统。而多媒体计算机指的是硬件设施，多媒体计算机是多媒体信息系统得以应用的平台。 2．试归纳叙述多媒体关键特性以及这些特性之间的关系。 多媒体的关键特性主要包括信息载体的多样性、交互性和集成性这三个方面，这既是多媒体的主要特征，也是在多媒体研究中必须解决的主要问题。 信息载体的多样性是相对于计算机而言的，指的就是信息媒体的多样化，有人称之为信息多维化；多媒体的第二个关键特性是交互性，多媒体系统将向用户提供交互式使用、加工和控制信息的手段，为应用开辟更加广阔的领域，也为用户提供更加自然的信息存取手段；多媒体的集成性主要表现在两个方面，一是多媒体信息媒体的集成，二是处理这些媒体的设备与设施的集成。 信息载体的多样性是集成性的基础，没有多种信息媒体，也就无法进行多媒体信息的集成化处理；而处理多媒体的设备与设施的集成性是实现交互性的前提，没有系统、网络、软硬件设施的集成，就无法为用户交互式使用、加工和控制信息提供平台。 3．为什么说多媒体缩短了人类信息交流的路径？人类与计算机进行信息交流的目的是什么？ 与以往的方法相比，计算机在数据处理方面有了很大的改善。计算机所提供的功能强大的数据组织和构造技术，如传统数据结构中的数组、向量、队列、堆栈、树和堆等，为动态地加工和处理数据提供了基础。高效的算法和高速的网络通信，大大地加强了用文字和数据表示概念的能力并加速了它的传递过程。但人类并不是仅仅依赖文本这一类单一的数据形式来传递所有的信息和接受概念的，图像、声音等多媒体信息都是人类获取和传递信息极为重要的渠道。图像的信息量最大，一幅画胜过千言万语，最直观、最能一目了然。而动态的影像视频和动画则更生动、更逼真、更接近客观世界的原型、更能反映事物的本质和内涵。声音和文字也是信息的重要媒体，综合应用不仅有利于接受，也有利于存储（记忆）和保留。这就意味着必须同时启动大脑的形象思维和逻辑思维，才能更好地获得更多更有用的信息。因此，通过多种感觉器官用多种信息媒体形式向人提供信息才算是更好的表达方法，它不仅加速和改善了理解，并且提高了信息接受的兴趣和注意力。多媒体正是利用各种信息媒体形式，集成地用声、图、文等来承载信息，也就是缩短信息传递的路径。 人类与计算机进行信息交流的目的是为了高效的获取、传递以及使用信息。计算机的发展使得人类的信息处理手段得到加强，高速的计算能力扩展了对数据进行重复计算的能力，大规模的存储扩展了记忆信息的范围，高速通信网使得我们可以同远在异地他乡的同事、朋友、亲人甚至陌生人进行快速的信息交换。这些机器成为我们与他人进行交流的中介。 第2章媒体及媒体技术 1．为什么说媒体具有不同的抽象层次？对媒体的抽象层次和性质进行小结。 在获得媒体语义的过程中，抽象起着十分重要的作用，这种抽象是复杂的，而且与任务有关。通常包括若干抽象层，每一个抽象层都包含着与具体的任务和问题域有关的模型。从接近具体感官的信息表示层到接近符号的信息表示层，信息的抽象程度递增，而数据量则递减。语义就是在从感官数据到符号数据的抽象过程中逐步形成的。对不同媒体来说，媒体的语义是处于不同层次上的。抽象的程度不同，语义的重点也就不同。
个人履历 教育背景: 2002-9---2006-02 在医学院药学系学习了所有药学专业的课程。 在医院中药房、西药房、住院药房、门诊药房、药库实习。熟 悉了医院工作环境和规章制度，及相关药事管理方面的工作。 在针剂，片剂和中药车间实习。熟悉了药品生产流程，质量控 制程序等相关方面的工作。使得在销售工作中对客户提出的相 关问题能够给出专业的答案。 2006-3---2006-6 在中药室学习。增加了对药品检验，鉴定等相关实验室知识。 并在此期间完成了毕业论文的设计，获得毕业答辩“优秀论 文”评定。 证书及技能 2004.9全国计算机等级三级证书 2005.12大学英语六级证书 能够熟练使用word,excel,PPT等各种办公软件，有良好的英语基础，但是口语欠佳，平时一直在努力学习spoken english 业务经验： 2007.5 在北京丰台区组织举行产品终端宣传会议 邀请终端药店，诊所及小医院共60多家参加，宣传公司的产品， 销售政策及未来市场规划，加强客户对公司品牌的认知以及对我公 司产品市场情况反馈。 2007.7在北京顺义区组织举行产品终端宣传订货会议 邀请终端药店，诊所及小医院共88家加，对公司各主要产品进行展 示，并举行了现场订货签单。进一步加强公司产品在北京地区的宣传 和推广。 2007.8 在石家庄和保定组织二级客户终端分销工作，进行了礼品促销；加
强了同二级客户的关系，加深了二级客户对我们的信任。 2007年，全年销量做到2700多万，居普药部门首位。 2008年，开始团队建设，负责北京，唐山，保定和石家庄区域团队协作。加强管理各区域业务员的二级客户分销工作，将分销工作做得更细致，更 深入。 2009．5，在北京平谷区组织举行产品终端宣传订货会议；6月在石家庄组织二级客户终端分销工作。 2010年—至今，依然负责北京及其周边地区的销售工作。 自我评价: ◆乐观、自信、积极向上 ◆很强的学习能力，能快速接受新事物 ◆较强的执行能力、沟通能力和良好的团队合作精神 求职意向：山西运城，西安或北京地区商务代表 Resume . Certifications and Skills 2004/09 National Computer Rank Examination Certificate. 3 2005/12 College English Test-6 2008/05-2008/07 The purchases/sales License of pharmaceuticals. Skillful in Microsoft Office(Word, Excel, PowerPoint, etc); Fluently in oral English and skillful in listening、reading、writing. Assignment experience
Introduction to Physiology Introduction Physiology is the study of the functions of living matter. It is concerned with how an organism performs its varied activities: how it feeds, how it moves, how it adapts to changing circumstances, how it spawns new generations. The subject is vast and embraces the whole of life. The success of physiology in explaining how organisms perform their daily tasks is based on the notion that they are intricate and exquisite machines whose operation is governed by the laws of physics and chemistry. Although some processes are similar across the whole spectrum of biology—the replication of the genetic code for or example—many are specific to particular groups of organisms. For this reason it is necessary to divide the subject into various parts such as bacterial physiology, plant physiology, and animal physiology. To study how an animal works it is first necessary to know how it is built. A full appreciation of the physiology of an organism must therefore be based on a sound knowledge of its anatomy. Experiments can then be carried out to establish how particular parts perform their functions. Although there have been many important physiological investigations on human volunteers, the need for precise control over the experimental conditions has meant that much of our present physiological knowledge has been derived from studies on other animals such as frogs, rabbits, cats, and dogs. When it is clear that a specific physiological process has a common basis in a wide variety of animal species, it is reasonable to assume that the same principles will apply to humans. The knowledge gained from this approach has given us a great insight into human physiology and endowed us with a solid foundation for the effective treatment of many diseases. The building blocks of the body are the cells, which are grouped together to form tissues. The principal types of tissue are epithelial, connective, nervous, and muscular, each with its own characteristics. Many connective tissues have relatively few cells but have an extensive extracellular matrix. In contrast, smooth muscle consists of densely packed layers of muscle cells linked together via specific cell junctions. Organs such as the brain, the heart, the lungs, the intestines, and the liver are formed by the aggregation of different kinds of tissues. The organs are themselves parts of distinct physiological systems. The heart and blood vessels form the cardiovascular system; the lungs, trachea, and bronchi together with the chest wall and diaphragm form the respiratory system; the skeleton and skeletal muscles form the musculoskeletal system; the brain, spinal cord, autonomic nerves and ganglia, and peripheral somatic nerves form the nervous system, and so on. Cells differ widely in form and function but they all have certain 生理学简介 介绍 生理学是研究生物体功能的科学。它研究生物体如何进行各种活动，如何饮食，如何运动，如何适应不断改变的环境，如何繁殖后代。这门学科包罗万象，涵盖了生物体整个生命过程。生理学成功地解释了生物体如何进行日常活动，基于的观点是生物体好比是结构复杂而灵巧的机器，其操作受物理和化学规律控制。 尽管从生物学整个范畴看，生物体某些活动过程是相似的——如基因编码的复制——但许多过程还是某些生物体群组特有的。鉴于此有必要将这门学科分成不同部分研究，如细菌生理学、植物生理学和动物生理学。 要研究一种动物如何活动，首先需要了解它的构成。要充分了解一个生物体的生理学活动就必须掌握全面的解剖学知识。一个生物体的各部分起着什么作用可通过实验观察得知。尽管我们对志愿者进行了许多重要的生理调查，但是实验条件需要精确控制，所以我们当前大多生理知识还是源于对其它动物如青蛙，兔子，猫和狗等的研究。当我们明确大多数动物物种的特定生理过程存在共同之处时，相同的生理原理适用于人类也是合理的。通过这种方法，我们获得了大量的知识，从而让我们对人类生理学有了更深入的了解，为我们有效治疗许多疾病提供了一个坚实的基础。 机体的基本组成物质是细胞，细胞结合在一起形成组织。组织的基本类型有上皮组织，结缔组织，神经组织和肌组织，每类组织都有各自的特征。许多结缔组织中细胞量相对较少，但是有大量的细胞外基质。相比而言，光滑的肌组织由大量密密麻麻的肌细胞通过特定的细胞连接组成。各种器官如脑，心脏，肺，小肠和肝等由不同种类的组织聚集而成。这些器官是不同生理系统的组成部分。心脏和血管组成心血管系统；肺，器官，支气管，胸壁和膈肌组成呼吸系统；骨骼和骨骼肌组成骨骼肌系统；大脑，脊髓，自主神经和神经中枢以及
Unit 1 Green pharmacy-herbal medicine 1) Plant kingdom once was mere pharmacy of the human race, but now when you get into the modern pharmacy, plant-derived drugs have been hardly found. 2) Although today the number of plant-based drugs has been decreased, the effective chemicals in many tables, capsule and bottle-contained drugs are originated from plant kingdom. 3) Among chemical substances contained in plants, some must be toxic, but some must be drugs available to us. 4) During the millions of years since man came to the earth, he has been doing experiments on a variety of plants about him. 5) There exist mistrust, suspicion and hostility between the orthodox medicine and herbal practitioners for many years, which are threatening the possibility of establishing good working relationship. 6) When we think of the effectiveness of quinine, the great contributions made by herbal medicine to medical science are quite evident. 7) However, in the past few decades, the number of newly-introduced drugs has obviously decreased. 8) The medical legacy of our motherland is an inexhaustible new-drug treasure, which remains us to tap with new methods. 9) If pharmacological method had not been introduced to the study of vinca rosea, the discovery of vincaleukoblastine would have been postponed by many years. 10) Western medicine hardly believes that someone who knows nothing of a disease mechanism could be capable of curing it. Unit 2 How does human body fight disease? People tend to believe that antibiotics were invented by human being, but in fact, they are purely natural products. Since Alexander Fleming, a British biologist discovered anti-microbial substance released by the Penicillium fungi in 1928, it has been learned that this substance can produce powerful antibiotic effect. In fact, antibiotics, are exactly manufactured by organisms, namely, bacteria and fungi, which people aim to destroy. After Fleming’s discovery of penicillin, Selma Walksman in 1943 isolated Streptomycin from a soil bacterium, Streptomycus griseus. Scientists have not made it clear completely why organisms can produce antibiotics. This question has become the topic for discussion. Why antibiotics are useful in medicine is that they can not only kill microbes, but also not kill the body cells as they do to the microbes, body cells are entirely different from those of bacteria cells, so that they can avoid being destroyed at the same time. Thus, antibiotics are called “magic bullet”because they may be particularly used to aim at certain microbes. This feature of antibiotics also makes them essentially different from anti-microbial agents: the latter tends to have poison to a majority of cells, whether the cells of bacteria or the body cells. Unit 3 Drug dependence Studies indicate that drug dependencies both a health problem and a social concern. The drug dependence affects not only individual’s health but also the public health at the same time. The drug use has obviously and severely negative effects on the human brain and physical health. But drug abuse and addiction have huge and potential threat, because whether the drug is used directly
《药学英语》课程教学大纲 一、课程教学目的与任务 开设药学英语旨在从培养高级应用型人才的目标出发，结合药学及相关专业学生毕业后的工作实际，力求为他们提供其未来工作岗位所需要的专业英语知识和技能。通过教学，提高学生借助辞典和其他工具书籍，阅读国外文献的能力，并为将来我国执业药师与国际接轨做准备。 二、理论教学的基本要求 学完该课程后，在知识、技能和能力上分别应达到的以下程度： 了解英文药学文献的写作特点和格式，学习如何分析和理解英语长句。英国药典和美国药典的背景知识和使用方法，了解FDA的职责和功能；理解各章节PartA部分课文意思及PartB部分药品说明书中的常见例句；掌握掌握药品说明书必须书写的10个项目及其常用词汇，能够归纳出一些常见的化学基团的英文词缀；能用所学知识书写简单的英语药品说明书。 三、实践教学的基本要求 本课程实践学时全部以课堂对话形式进行，无单独实验项目。 四、教学学时分配
五、教学内容 Unit1 教学目的和要求：通过本章节学习，理解课文意思；掌握药品说明书的作用、项目；能够归纳出一些常见的化学基团的英文词缀。 教学重点：常用专业单词，如Pharmaceutical等的用法。 教学难点：文章翻译；常见的化学基团的英文词缀。 主要内容：PartAForeign Investment in Chinese Pharmaceutical Sector；PartB第1节药品名称；PartCChina—from self-sufficiency to World Leadership。 Unit 2 教学目的和要求：通过本章节学习,使学生理解课文意思；掌握常用专业单词，如supervision等的用法；掌握描述药物性状的常见句型；掌握药物性状的常用表达方式。 教学重点：常见的药物性状。 教学难点：常见描述药物性状的单词或短语。 主要内容：PartAFDA: Policeman or Teacher；PartB第2节药物性状；PartC Data Required for Drug Approval。 Unit 3 教学目的和要求：通过本章节学习,使学生掌握英文药品说明书中描写适应症的常见描短语或句型，常用专业单词，如临床药理(Clinical Pharmacology)、药效(Potency)、毒性(Toxicity)等。 教学重点：英文药品说明书中描写适应症的常见描短语或句型。 教学难点：文章翻译。 主要内容：PartA Pharmacological Tablet；PartB第2节药物性状。 Unit 4 教学目的和要求：通过本章节学习,使学生理解课文意思；掌握英文药品说明书中常见描写适应症、禁忌症的短语或句型。 教学重点：英文药品说明书中常见描写适应症、禁忌症的短语或句型。 教学难点：文章翻译。 主要内容：PartA Chemistry and Matter；PartB第4节适应症、第5节禁忌症。 Unit 5 教学目的和要求：通过本章节学习,使学生掌握英文药品说明书中描写用法用量及不良反应的常见短语或句型。常用专业单词，如常用表示剂量的术语平均剂量（average dose）、常用的剂量单位表示法、每次给药次数的表示方法：每隔…小时（every …hours）、每日三次（three times a day /daily)等。 教学重点：英文药品说明书中描写用法用量及不良反应的常见短语或句型。
本篇包括人卫第四版Unit 3B，Unit4A，5A，8A，10A，12AB，13A等七篇课文Unit 3 Text B The Other Side of Antibiotics 抗生素的另一面 Antibiotics have eliminated or controlled so many infectious diseases that virtually everyone has benefited from their use at one time or another. Even without such personal experience, however, one would have to be isolated indeed to be unaware of the virtues, real and speculative, of these “miracle” drugs1. The American press, radio, and television have done a good job of reporting the truly remarkable story of successes in the chemical war on germs. What′s more, any shortcomings on their part have been more than made up for by the aggressive public relations activity of the pharmaceutical companies which manufacture and sell antibiotics. 抗生素可以消除或控制很多种感染疾病，以致几乎每人生病时都习惯于使用它而受益，但是如果一个人没有这样的亲身经历，他必定是离群索居才会不知道这些“特效药物”或真实或推测的优点。美国的出版物、电台或电视台用大量的篇幅报道了有关对细菌的化学战中获得的这些显着功绩。而它的缺点却被生产和销售抗生素的制药公司通过公关活动掩藏了。 In comparison, the inadequacies and potential dangers of these remarkable drugs are much less widely known. And the lack of such knowledge can be bad, especially if it leads patients to pressure their doctors into prescribing antibiotics when such medication isn’t really needed, or leads them to switch doctors until they find one who is, so to speak, antibiotics-minded2. 相比而言，使用这些药物的危险性并不广为人知。对这种知识的缺乏将更糟糕，特别是当患者要求医生开处方用抗生素而事实并不需要，或患者频繁地更换医生直至找到一个同意开抗生素处方的医生。 Because the good side of the antibiotics story is so very well-known, there seems more point here to a review of some of the immediate and long-range problems that can come from today’s casual use of these drugs. It should be made clear in advance that calamities from the use of antibiotics are rare in relation to the enormous amounts of the drugs administered. But the potential hazards, so little touched on generally, do need a clear statement. 因为抗生素的好的一面已广为人知，今天抗生素的滥用导致短期或长期问题。我们预先应该知道与抗生素的巨大的使用量相比,它产生危害的例子是少见的。但是，尽管十分少见，需要对这种潜在的危险作一个清楚的说明。 The antibiotics are not, strictly speaking, exclusively prescription drugs. A number of them are permitted in such over-the-counter products as nasal sprays, lozenges, troches, creams, and ointments. Even if these products do no harm there is no point whatsoever in using them. If you have an infection
广东药学院 精品课程、优质课程申报书 课程名称药学专业英语 课程性质□公共必修课□基础必修课 □专业主要课程□其它 申报类型□精品课程□优质课程 课程负责人曾爱华 所属二级学院药科学院（盖章） 所属教研室药学综合教研室 申报日期2009 年 5 月18 日 广东药学院教务处制
1.课程基本信息及指导思想
课程教育思想观念 《药学专业英语》课程是药学英语特色专业的一项重要专业课，是学生在学完公共英语之后的延续，其要旨在于帮助学生完成从基础英语到专业英语的过渡。 药学专业英语是一门英语与药学交叉的科目，在讲授专业英语课时，首先主要通过教师在课堂上用英语讲授，配以课堂讨论，并要求学生以英语发言，提高学生的英语听说能力；其次布置大量阅读材料让学生自学，通过教师的适当检查，或让学生在课堂上讲解，提高学生阅读专业英语书籍的能力；最后将部分专业阅读材料布置给学生做学习翻译的课外练习，在课堂上讨论学生作业中的错误和翻译技巧问题，提高学生翻译的技能。在教学过程中，注意培养学生独立思考和学习的能力，使学生在课程结束后，在实际工作中，能较流畅地阅读专业英语资料，为进一步的工作和科研奠定基础。 我们认为，在当今社会发展日新月异的情况下，在授课过程中我们力争做到面向每个学生，充分考虑学生的个性，充分发挥每一位学生的主动性和潜能，进而建立平等、和谐的师生关系。从教师的职责而言： （1）教师是学生学习的设计者与帮助者。 （2）教师应成为创新思维型、学者型教师。 （3）教师要与时俱进，终身学习。
为了提高教师本身的素质，我们认为： （1）积极参加教学研究活动是转变教师教育观念的最有效途径，鼓励教师参与教学研究，尤其是参与教学方法改革、课程改革等方面的研究。多参加教学课题的申报、实施和积累。 （2）观察学习。要求年轻教师积极参加听教学经验丰富老教师的授课，使教师能在学习别人良好经验的过程中更新自己的教育方式。观察学习是学习者通过有意识的观察和学习，并对自己观察到的内容进行消化和吸收，在此基础上加以创新。 （3）教学小组研讨会。 针对某一有代表性的教育、教学事件，教师之间可以展开小组讨论。教研室要积极进行教师教学集体备课。 说明：1、本申报书各项内容阐述时请注意以事实和数据为依据，各表格不够可加页。 2、申报精品课程必须有课程网站，未被评选为精品课程者自动参与优质课程评选。 2. 师资队伍
一、熟悉下列句子的翻译 1. In addition to the revolution in new classes of drugs, an equally momentous revolution is taking place in drug delivery. 除药物种类的革命外，药物给药系统也在进行一场同样令人震撼的革命。 2. The body can make about a trillion different antibodies, produced by shuffling and reshuffling their constituent parts. 通过对构成成分的改组和再改组，机体可以产生约一万亿个不同的抗体。 3. Under current law, all new drugs need proof that they are effective, as well as safe, before they can be approved for marketing. 现有法律要求，所有的新药都必须具有其有效、安全的证据才能被批准上市。 4．There is no agreement whether nursing mothers could use Alexan. 哺乳期妇女是否能用爱力生尚无统一意见。 5. The prescription must be signed and dated by the practitioner and include his address. 处方必须由医生亲笔签名，并注明日期和医生的地址。 6. Cells possess a nucleus which contains genetic information in the form of DNA. 细胞含有一个细胞核，其中含有以脱氧核糖核酸（DNA）形式表达的基因信息。 7. A drug that is not covered by patent rights may be available in several proprietary formulations of the same generic preparation. 没有专利权保护的药物可以用于同一个仿制剂型的多个专利配方中。 8. When a drug is used by millions, there are certain to be adverse reactions even though the risk to any individual is small. 当某种药物被数百万人使用时，肯定会有不良反应出现，尽管具体到个人，这种危险性并不大。 9. The end point is also called equivalent point, since the titrant and tested sample are chemically equivalent. 滴定终点也称为等当点，因为测定剂和被测样本在化学量上是相等的。10. It is estimated that less than 30% of the hypertensive patients have their
药学英语翻译练习 I. Translate the following phrases and sentences into Chinese A Phrases translation 1. Lidocaine hydrochloride 盐酸利多卡因 2. procaine sulph(f)ate 硫酸普鲁卡因 3. APC: ( Aspirin Phe n acetin Caffeine) 阿司匹林，非那西丁，咖啡因 4. Di a zepam 地西泮 B Sentences translation 1. Despite problems of cultural, ethical and regulatory differences, a growing number of foreign companies have begun multi-centre phase III clinical trials in China. 尽管由于文化，伦理和规定的不同，越来越多的国外公司开始在中国进行3期临床试验。 2. The interest by US and European pharmaceutical companies in doing something more than a small phase IV trial to meet China’s minimal licensing criteria was modest at best. 美国和欧洲医药企业在中国进行超越4期临床试验达到中国注册标准的兴趣并不大。 3. By law, the FDA has responsibility to oversee the purity, quality, safety, usefulness, and related characteristics of the nation’s food, drug, and cosmetic supply. 根据规定，FDA负责监督国家食品，药品和化妆品的纯度，质量安全，效果和相关特性。 4. The FDA must primarily rely on the voluntary compliance of those who operate within the professions and industries that are responsible for the products which the FDA has jurisdiction. 对于属于FDA监管范围的产品，FDA主要依靠那些负责生产的工厂和企业自觉遵守。 5. According to the government’s strategic plan for 2006—2050, China’s total drug sales are expected to reach RMB 700 billion by 2010, an average growth rate of just over 16% from 200 6. 根据2006-2050政府的战略计划，到2010年中国总体药物销售量期望达到7000亿元，也就是说从2006年开始平均增长率超过16%。 6. The use of Western medicines in China is usually said to have begun in 1952, when the antibiotic chloram p henicol(氯霉素) was first synthesized and produced domestically. 人们通常说中国使用的西药始于1952年，当时中国首次生产氯霉素。 7. In fact over 1,500 bulk drugs, fine chemical ingredients and intermediates are currently made in China and sold in 3,500 finished formulations. 事实上有1500多种原料药，即化学原料和中间体在中国生产，并且有3500种成品药由中国销售。
Unit One 1. A full appreciation of the physiology of a living organism must be based on a sound knowledge of its anatomy. Anatomy does not merely study the separation of parts, but the accurate description of the morphologies and functions of different organs. 2.Our daily food intake must match requirements and any excess must be excreted for balance to be maintained. 3.The process of stabilization of the internal environment is called homeostasis and is essential if the cells of the body are to function normally. 4.Human cells have the ability to break down large molecules to smaller ones to liberate sufficient energy for their activities. 5.As long as normal conditions are maintained in this internal environment, the cells of the body continue to live and function properly. Unit Two 1.Biochemistry asks how the thousands of different biomolecules interact with each other to confer the remarkable properties of living organisms. 2.Enzymes are catalysts that accelerate the rates of biological reactions. Each enzyme is very specific in its foundation and acts only in a particular metabolic reaction. 3.One of the most fruitful approaches to understand biological phenomena has been to purify an individual chemical component, such as protein, from a living organism and to characterize its chemical structure or catalytic activity. 4.The chemical principles that govern the properties of biological molecules include the covalent bonding of carbon with itself and with other elements and the functional groups that appear in common biological molecules, etc. 5.The basic unit of DNA is a linear polymer of four different monomeric subunits, deoxyribonucleotides, arranged in a precise linear sequence. Unit Four 1.The science of the effects on the body is called pharmacology, and the scientists who study it are pharmacologists. Pharmacology is not a science that can be studied on its own, but that closely related to other branches of science. Pharmacologists should not only understand he normal processes that take place in the body, but know how the functions of the body are affected by disease. 2.For physicians and medical students, the scope of pharmacology is not so expansive as its common definition. The clinician is interested primarily in drugs that are useful in the prevention, diagnosis, and treatment of human disease, or in the prevention of pregnancy. 3.All physicians should share the responsibility to resolve kinds of sociological problems caused by the abuse of drugs. Properly used, drugs are great blessing to mankind; improperly used, they could destroy human race. When a patient, particular the elderly is prescribed frequently to take more than one therapeutic agent, drug interactions resulting in toxicity will occur. 4.At one time, it was essential for the physician to have broad botanical knowledge, because they had to possess the ability and skill to select proper plants from which to prepare his own