Developmen of New Drugs.doc

Development of New Drugs Aim 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. 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. 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. 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 development. 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 clear. 2 Drug development strategies Several strategies have been used in the development of new drugs. Over the years all have had success but no single approach has been consistently successful. Serendipity, luck an