Comprehensive Guide to Pharmaceutical Regulatory Science" is an essential textbook designed to provide pharmaceutical professionals, students, and researchers with a deep understanding of regulatory science in the pharmaceutical industry. This book covers a wide range of topics including drug discovery, clinical trials, regulatory approval processes, and post-market surveillance.
Key Features:
In-depth Coverage: Learn about the complete regulatory landscape, including the stages of drug discovery and development, clinical trials, regulatory approval processes (NDA, IND, ANDA), and international guidelines (FDA, EMA, ICH).
Authoritative Insights: Authored by renowned professionals with over 30 years of combined experience in pharmaceutical education, regulatory affairs, and pharmaceutical biotechnology.
Global Perspective: Detailed insights into the regulatory frameworks of the US, EU, Japan, Canada, and India, with practical applications for professionals working in these regions.
Real-World Applications: Understand the complexities of pharmaceutical regulation and how to navigate the approval process for drug products in various international markets.
Perfect for Professionals & Students: This book is ideal for students pursuing B. Pharm, M. Pharm, PhD in pharmaceutical sciences, and for professionals seeking to deepen their knowledge of pharmaceutical regulatory practices.
