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Clinical Research Principles Practice and Perspective

by [Mittal, Niti, Medhi, Bikash]

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Description

- Comprehensive content covering all aspects of clinical research.

- Evolving paradigms in clinical research, e.g. modelling and simulation, artificial intelligence, etc.

- Milestones in the evolution of drug regulations in India

- Drug regulatory framework in India and key ICH countries.

- Evolution of drug pricing mechanisms and IPRs in India.

- Updated text incorporating the New Drugs and Clinical Trials Rules 2019; Guidelines on BA/BE studies; ICMR National Ethical Guidelines 2017; National Guidelines for Stem Cell Research 2017; Medical Devices Rules 2017.

- Latest amendments and guidelines on ethics committees, informed consent, electronic informed consent, compensation and ICMR Policy on Research Integrity and Publication Ethics 2019.

- Templates for various documents like patient information sheet, assent document, case report form, adverse event reporting form etc.

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Product Details

  • Pharmamed Press Brand
  • Apr 1, 2023 Pub Date:
  • 9789389974447 ISBN-13:
  • 9389974445 ISBN-10:
  • 508.0 pages Hardcover
  • English Language
  • 9.25 in * 1.13 in * 7.5 in Dimensions:
  • 2 lb Weight: