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Clinical Research Regulations: Principles, Practices, and Global Perspectives is an authoritative guide to the ethical, scientific, and regulatory foundations of modern clinical research. Written by Prof. Rajiv Dahiya and Dr. Muralidhar Rao Akkaladevi, this book takes readers inside the complex world of drug development, medical device evaluation, and global compliance standards.
From early-phase microdosing trials to post-marketing surveillance, the authors reveal how clinical studies are designed, conducted, and regulated across India, the USA, and the European Union. With clear explanations and real-world insights, the text explores critical topics such as ICH-GCP guidelines, informed consent, research ethics, institutional review boards, and data safety monitoring boards.
Students, investigators, regulatory professionals, and healthcare practitioners will find this book invaluable as it bridges the gap between theory and practice. Each chapter connects global regulations with practical applications, helping readers understand not only what the rules are—but why they matter.
As the clinical research landscape grows more complex, this book offers a trusted roadmap for navigating international regulations while safeguarding patient safety and scientific integrity. Comprehensive yet accessible, it is an essential resource for anyone seeking to excel in the field of clinical research.
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Prof. RAJIV DAHIYA, Dr. MURALIDHAR RAO AKKALADEVI
Prof. Rajiv Dahiya, a prominent figure in the field of pharmaceutical sciences, is currently associated with the School of Pharmacy at The University of the West Indies, St. Augustine, Trinidad & Tobago. He serves as the President of the Association of Pharmacy Professionals (APP), the Editor-in-Chief of the Bulletin of Pharmaceutical Research (BPR), and the Executive Editor of APP Scientific Updates (ASU). His extensive educational background spans degrees in pharmacy and pharmaceutical sciences from prestigious institutions in India. Prof. Dahiya has authored 99 publications, contributing significantly to pharmaceutical research and academia.
Dr. A. Muralidhar Rao is the distinguished Principal of St. Mary's College of Pharmacy and President of the Association of Pharmacy Professionals for Telangana State. With over 25 years of teaching experience, Dr. Rao has made significant contributions to pharmacy education and research. He is the author of 15 books on various pharmacy topics and has published numerous research papers.Dr. Rao is a Fellow of the Association of Pharmacy Professionals (APP) and the Indian Science Congress Association (ISCA). He is also a life member of the Association of Pharmaceutical Teachers of India (APTI), the Indian Pharmacy Graduates' Association (IPGA), and the Indian Pharmacological Society (IPS). A respected speaker, he has presented at national and international conferences, sharing his expertise and inspiring others in the field
