Bajaj J S
Indian J Physiol Pharmacol. 1981 Apr-Jun;25(2):95-104.
The drug development process is complex. It takes about 5--7 years before a compound synthesised in the laboratory can be made available the general practitioner for therapeutic usage. Furthermore, only a few of the compounds developed and synthesised in the laboratory with possible hope of therapeutic application, satisfactorily pass through all the stages of development process. Complete development of a new drug may cost 10--15 million rupees and needs the technical expertise of the highest order. Obviously this calls for tremendous financial and human resources. It is, therefore, imperative that research investments are properly planned and wisely made. It should be a well coordinated team effort with deep considerations of economic management. Clinical pharmacology plays an essential and a meaningful role in this process and its interactions with the pharmaceutical industry should be such as to ensure therapeutic efficacy and safety of new drugs.
药物研发过程十分复杂。从实验室合成的化合物到可供全科医生用于治疗,大约需要5至7年时间。此外,在实验室研发和合成的、有望用于治疗的化合物中,只有少数能顺利通过研发过程的所有阶段。一种新药的全面研发可能耗资1000万至1500万卢比,并且需要最高水平的技术专长。显然,这需要大量的资金和人力资源。因此,必须妥善规划并明智地进行研究投资。这应该是一个精心协调的团队努力,并充分考虑经济管理。临床药理学在这一过程中发挥着至关重要且有意义的作用,它与制药行业的互动应确保新药的治疗效果和安全性。