Pharmaceutical Regulatory Affairs Principles and Practices

Product Description

This book provides concepts procedures guidelines and regulatory affairs in drug development. Pharmaceutical Regulatory Affairs: Principles and Practices begins with a detailed overview of the drug development life cycle from initial discovery and preclinical research to clinical trials and market approval addressing scientific regulatory and ethical considerations at each stage. The book covers the evolution of global trade agreements like the General Agreement on Tariff and Trades (GATT) and the World Trade Organization’s (WTO) impact on pharmaceuticals highlighting issues surrounding pharmaceutical patents and intellectual property rights. It discusses the importance of the Scale-Up and …