Synopsis

A comprehensive guide to the complex and lengthy process by which a drug arrives on the market. The process has elements of scientific research, medical ethics, business, and regulation; statistics show that out of 5,000 compounds with initial promise, five will go into human clinical trials and one will become an approved drug. The reference lists current FDA and European guidelines and covers regulatory authorities and processes in Japan and China. Of interest to professionals in the pharmaceutical industry as well as students of pharmacy, medicine, or life sciences and others interested in drug discovery. Ng is manager of regulatory affairs for the Biopharmaceutical Manufacturing Technology Centre, Singapore.