A Practical Guide to Human Research and Clinical Trials

M. U. R. Naidu, P. Usha Rani

January 29, 2013 by CRC Press
Reference - 350 Pages
ISBN 9781466591172 - CAT# K20499


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  • Covers drugs and devices, issues related to investigators, regulatory requirement and pre-clinical and clinical development
  • Discusses project design and planning of single and multiple centre clinical trails, good clinical research practice, ethics, quality assurance, data safety monitoring and archiving
  • Includes coverage of biomedical statistics


Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinical focuses on ethics, regulations, and guidelines.

Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.

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