CLINICAL RESEARCH REGULATIONS: Principles, Practices, and Global Perspectives - Tapa blanda

Sinopsis

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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