Clinical Research: Principles, Practice and Perspective

By Bikash Medhi and Niti Mittal

- 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.

• Format: Hardcover
• Language: English
• ISBN: 9389974445
• ISBN13: 9789389974447
• Release Date: April 2023
• Publisher: Pharmamed Press
• Length: 508 Pages
• Weight: 2.38 lbs.
• Dimensions: 1.1" x 7.5" x 9.3"