Comprehensive Guide to Pharmaceutical Regulatory Science - Brossura

Dr. K. Nagasree; Dr. Konda Shravan Kumar; Dr. K. N. V. Rao

Brossura

ISBN 13: 9798899064388

Casa editrice: Notion Press, 2025

Riassunto

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.

Dettagli dell'edizione

• Editore: Notion Press
• Data di pubblicazione: 2025
• Lingua: Inglese
• ISBN 13: 9798899064388
• Rilegatura: Copertina flessibile
• Numero di pagine: 386
• Contatto del produttore: non disponibile
• Persona responsabile: non disponibile