河南大学12年药学英语.docVIP

Drug development aims to produce a novel therapeutic agent which is superior in efficacy to existing remedies and which causes less frequent or less severe adverse effects. 药物研制旨在生产出在疗效上优于现存药品，且副作用发生率减少、程度降低的新型治疗药物。 The development of a new therapeutic agent involves a multidisciplinary group in many years of work. Formerly, drugs were extracted from natural plant and animal sources. Therapeutic use was empirical and based on traditional experience. 新药研制涉及到多学科研究人员多年的共同研究成果。以前药物是由天然植物和动物体提取的，其治疗作用全凭经验和传统做法来确定的 Over the last 80 years an impressive number of drugs have been synthesized chemically. With the development of genetic engineering and the production of monoclonal antibodies it is likely that even more agents will be produced artificially. 在过去的80年中，人们通过化学合成，研制出大量药物。随着遗传工程学和单克隆抗体技术的发展，人们必将研制出更多新药。 Synthetic techniques have produced pure substances. This has led to increased specificity of action and, in some cases, greater efficacy and reduced toxicity. Unfortunately new drug development is expensive, and only a few substances (less than 1%) of those developed are actually marketed and used in practice. 合成技术已研制出高纯度药物，这不仅提高了治疗的专一性，有时还提高了疗效，减少了毒副作用。遗憾的是，新药研制的费用太高，只有少量已研制出的药物（不到1%）被实际推向市场，投入使用。 The range of novel chemical entities developed has occasionally led to unexpected toxicity. As a consequence, most governments have established bodies to regulate drug marketing, e.g. the committee on Safety of Medicines in Britain, and the Food and Drug Administration in the USA. These agencies supervise clinical research on new drugs and license new products. 在研制出的新型化学制品中，有些会产生意想不到的毒副作用。因此，大多数政府都设有药品发行的调节机构，例如：英国的药品安全委员会和美国的食品药品管理局。这些机构负责管理新药的临床研究和审批发行事宜。 Although they serve to protect the public and are seen to do so, the statutory procedures that must be followed in applying for a license for a new drug add greatly to the costs and time of development. 尽管他们的职责是保护公众,他们也确实这么做了,但申报新药必须遵循的诸多法定程序却大大增加了研制的成本和时间 There is some evidence that the rate of introduction of entirely