Regulatory Affairs - Veintramuthu, Sankar; S, Pranav Ragavendra
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"Regulatory Affairs: Basic Protocols" provides a comprehensive guide to the basic concepts and protocols in the pharmaceutical industry. Written in a clear and concise manner, this book covers topics including documentation, chemistry, manufacturing, and controls, as well as the investigation of medicinal product dossier and the development of clinical trial protocols. Throughout the book, readers will learn about the concept of innovator and generic drugs, drug development, and the regulatory guidance and guidelines for filing and approval. This book also explores the preparation of dossiers…mehr

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Produktbeschreibung
"Regulatory Affairs: Basic Protocols" provides a comprehensive guide to the basic concepts and protocols in the pharmaceutical industry. Written in a clear and concise manner, this book covers topics including documentation, chemistry, manufacturing, and controls, as well as the investigation of medicinal product dossier and the development of clinical trial protocols. Throughout the book, readers will learn about the concept of innovator and generic drugs, drug development, and the regulatory guidance and guidelines for filing and approval. This book also explores the preparation of dossiers and their submission to regulatory agencies in different countries, as well as post-approval regulatory requirements for actives and drug products. Readers will also gain valuable insights into the submission of global documents in CTD/eCTD formats, clinical trial requirements for approvals for conducting clinical trials, pharmacovigilance, and the process of monitoring clinical trials. "Regulatory Affairs: Basic Protocols" is an indispensable resource for anyone looking to gain a deeper understanding of the regulatory affairs landscape in the pharmaceutical industry. With clear descriptions, helpful figures, and illustrative examples, this book will make the subject more accessible and interesting for any reader.
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Autorenporträt
Sankar Veintramuthu, Vice Principal, Professor and Head, Dept. of Pharmaceutics, P.S.G. College of Pharmacy, Coimbatore (Tamil Nadu), is an expert in Biopharmaceutics and Pharmacokinetics. He has been awarded many best research paper awards. He is the recipient of Best Pharmacy Teacher from The Tamil Nadu Dr. MGR medical university, Chennai, and PSG Son's and Charites, Coimbatore. He has participated in 4 International and 12 National conferences. With funding support from the Tamil Nadu State Council for Science and Technology, Chennai, Indian Council of Medical Research (ICMR), New Delhi, All India Council for Technical Education, New Delhi, and Department of Science and Technology, New Delhi, he has organized 5 conferences/ seminars. He is the Editor of the International Journal of Pharma Research and a Research Reviewer for two international journals namely Informa World Journal (UK) and Biosciences Asia (Thailand). He has received two funded projects from CSIR and The Tamil Nadu Dr. MGR Medical University. He has guided 35 M pharm and 5 Ph.D. He is an active member of pharmacy bodies such as IPA, APTI, IPGA, and IHPA. To his credit, he has one patent and one textbook on Novel Drug Delivery Systems, and 91 research papers. He has also published two book chapters.