Text Book of Pharmaceutical Regulatory Science for the Students of B.Pharm 8th Semester

• Author Details: Prof. (Dr.) Ravinesh Mishra, Dr. Bhartendu Sharma, Dr. Priya Sharma
• ISBN: 978-93-48565-95-2
• Speciality: Pharmaceutical Regulatory Science

“Text Book of Pharmaceutical Regulatory Science” is a comprehensive guide that explores the principles, practices, and evolving landscape of pharmaceutical regulations governing the development, approval, manufacturing, and marketing of pharmaceutical products. This book is designed to bridge the gap between regulatory theory and practical application, making it an essential resource for students, academicians, researchers, and professionals in the pharmaceutical industry. By integrating foundational concepts with contemporary regulatory challenges, it serves as a vital tool for understanding the complex and dynamic field of drug regulation.
The book covers a wide array of topics, beginning with an in-depth examination of the drug development process—from preclinical research to post-marketing surveillance. It provides a thorough analysis of regulatory frameworks in India, including the Central Drugs Standard Control Organization (CDSCO), as well as international regulations such as those enforced by the US Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and the International Council for Harmonisation (ICH) guidelines. Additionally, the text delves into critical aspects of intellectual property rights (IPR), patent laws, and regulatory exclusivity, which are crucial for protecting innovations in the pharmaceutical sector.
Quality assurance (QA) and quality control (QC) in pharmaceutical manufacturing are discussed in detail, emphasizing Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP). The book also explores the design, execution, and ethical considerations of clinical trials, along with the growing importance of pharmacovigilance in monitoring drug safety post-approval.
With clear explanations, illustrative case studies, and real-world examples, this book aims to equip readers with the knowledge and skills required to navigate regulatory environments effectively. Whether preparing for regulatory examinations, engaging in research, or ensuring compliance with global standards, this text serves as an indispensable reference for anyone involved in the pharmaceutical and life sciences industries. Its practical approach ensures that readers not only understand regulatory requirements but also learn how to apply them in real-world scenarios, fostering excellence in pharmaceutical regulatory science.

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