新藥評估

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.

新藥評估

新藥研制涉及多學科研究人員多年的共同研究成果。以前藥物是從天然植物和動物 中提取的，其治療作用全憑經(jīng)驗和傳統(tǒng)作法來確定的。在過去的80年中，人們通過化學 合成，研制出大量藥物。隨著遺傳工程學和單克隆抗體技術的發(fā)展，人們必將研制出更多 新藥。

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. 合成技術已研制出高純度藥物，這不僅提高了治療的準確性，有時還提高了療效，降 低了毒副作用。遺憾的是，新藥研制的費用太高，只有少量已研制出的藥物(不到1%)被 實際推向市場，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. 在研制出的新型化學制品中，偶爾會產(chǎn)生意想不到的毒副作用。因此，大多數(shù)政府都設有藥品上市管理機構，例如:英國的藥品安全委員會和美國的食品和藥品管理局。這些機構負責管理新藥的臨床研究和頒發(fā)新藥證書。然而，盡管其作用是保護公眾利益，但申報新藥審批所必須遵循的諸多法律程序卻大大增加了研制的成本和時間。

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. 有跡象顯示，全新藥物投入使用的速率正在下降。這一現(xiàn)象是否可以反映企業(yè)經(jīng)濟 壓力增加，或者是新藥數(shù)量不足或研制能力下降，具體原因尚不清楚。

醫(yī)學英語