Textbook of Clinical Research: Principles, Methods, and Practice (Dr. Naga Subrahmanyam S, Dr. G.V. Nagaraju, Dr. Meruva Swathi, Sura Srivardhini.)
Edition / Volume
I
Hard Copy
$ 30.00
(INR 299.00)
Pages
138
Description
Clinical Research stands as a critical pillar of modern healthcare, bridging the gap between drug discovery and therapeutic application. This book, Clinical Research for Pharm.D V Year, is designed to provide students with a comprehensive overview of the drug development and clinical research process, equipping them with the knowledge essential for a successful career in this field. The text covers the complete trajectory of drug development, from the initial stages of pharmacological and toxicological research to Investigational New Drug (IND) applications, drug characterization, and formulation. The second section focuses on the clinical development of drugs, beginning with an introduction to clinical trials and the rigorous phases each potential therapy must pass through to ensure its efficacy and safety. This book highlights the importance of Good Clinical Practice (GCP), addressing both International Council for Harmonisation (ICH) and Central Drugs Standard Control Organization (CDSCO) guidelines, as well as ethical standards in clinical research. Students will also find detailed explanations of the roles and responsibilities of key clinical trial personnel, such as sponsors, investigators, clinical research associates, and regulatory authorities. Recognizing the importance of patient welfare, this book emphasizes ethical guidelines, informed consent, and safety monitoring procedures that safeguard participant rights. Topics on data management, study document design, and post-marketing surveillance offer insights into maintaining data integrity and patient safety even after a drug reaches the market. Through clear explanations and structured content, this book aims to serve as a practical and foundational resource for Pharm.D students. We hope it empowers readers to approach clinical research with a solid ethical grounding and a deep understanding of the rigorous standards required in this field.