新药评估

Evolution of a new drug

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. 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.

新药评估

新药研制涉及多学科研究人员多年的共同研究成果。以前药物是从天然植物和动物 中提取的，其治疗作用全凭经验和传统作法来确定的。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准确性，有时还提高了疗效，降 低了毒副作用。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，投人使用。

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. 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 development1. 在研制出的新型化学制品中，偶尔会产生意想不到的毒副作用。因此，大多数政府都设有药品上市管理机构，例如:英国的药品安全委员会和美国的食品和药品管理局。这些机构负责管理新药的临床研究和颁发新药证书。然而，尽管其作用是保护公众利益，但申报新药审批所必须遵循的诸多法律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 novel agents is slowing down. Whether this reflects economic pressures or diminished novel synthetic capacity or ability is not clear2. 有迹象显示，全新药物投入使用的速率正在下降。这一现象是否可以反映企业经济 压力增加，或者是新药数量不足或研制能力下降，具体原因尚不清楚。

医学英语