Description
Clinical trials are the mainstay for bringing out new drugs to the market and constitute approximately 70% of the total time and money spent in drug development. Typically it takes approximately 12 years and US$ 1 billion to bring one new drug from conception to market out of which 6 to 7 years are usually spent in various phases of clinical trials. In order to develop a comprehensive understanding on clinical research, it is important to understand the overall drug discovery process.This comprehensive and well-organized text is grounded in real-world applications of theoretical concepts of Drug discovery and development. It properly explains how many and what clinical trials are conducted to bring any medicine in the market for human consumption. It highlights the regulatory environment of India w.r.t to Clinical research, trials, and drug development. A very easy way to understand what are the roles and responsibilities of various clinical trial stakeholders. Basically, its a step by step guide for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, government and legal professions. The text provides exemplary coverage of all the relevant issues. The definitive book on the subject.
