"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 ...
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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 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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Add this copy of Regulatory Affairs: Basic Protocols to cart. $109.40, good condition, Sold by Bonita rated 4.0 out of 5 stars, ships from Santa Clarita, CA, UNITED STATES, published 2024 by Pharmamed Press.
Add this copy of Regulatory Affairs: Basic Protocols to cart. $144.29, new condition, Sold by Just one more Chapter rated 4.0 out of 5 stars, ships from Miramar, FL, UNITED STATES, published 2024 by Pharmamed Press.
Add this copy of Regulatory Affairs: Basic Protocols to cart. $145.85, new condition, Sold by Bonita rated 4.0 out of 5 stars, ships from Santa Clarita, CA, UNITED STATES, published 2024 by Pharmamed Press.
