药学英语翻译

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