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Explore the complexities of clinical research regulations in this comprehensive volume, Clinical Research Regulations: Principles, Practices, and Global Perspectives. Edited by Prof. Rajiv Dahiya and authored by Dr. Muralidhar Rao, this book offers an in-depth look at the legal and ethical frameworks governing clinical trials across the globe.
Spanning 25 chapters, the book covers essential topics including phases of clinical trials, ethical considerations, and global regulatory standards. It provides a structured approach, making it a go-to reference for pharmacists, researchers, and regulatory professionals.
This guide emphasizes international guidelines, ensuring readers stay informed about the FDA, EMA, and ICH-GCP regulations. It also addresses emerging trends in medical device investigations and biostatistical applications, making it a must-read for those involved in the clinical research process.
This text is a valuable resource for anyone looking to stay abreast of the evolving landscape of clinical trials and global harmonization efforts in clinical research.
Key Features:
Phases 0-IV of Clinical Trials
Global Regulatory Standards (India, USA, EU)
Ethics in Clinical Research
Medical Device Clinical Investigations
Comprehensive Biostatistics for Clinical Research
Informed Consent Process & Documentation
Role of Institutional Review Boards (IRBs) and Data Safety Monitoring Boards (DSMBs).
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
