Comprehensive Guide to Pharmaceutical Regulatory Science
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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 internationa...
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.
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