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