The Drugs and Clinical Trial Rules: An Overview

Authors

  • Vishal Vennu School of Pharmacy, Lingaya’s Vidyapeeth, Faridabad, India and Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.

DOI:

https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH1

Keywords:

Clinical trial, researchers, rule, regulation, drug, safety, India

Abstract

Globally, most nations follow the regulations to closely supervise clinical trials to evaluate their data integrity, protect patients' safety, and assess sites and sponsors' adequacy. The chapter provides an overview of these clinical trial regulations. The chapter also highlights the clinical trial regulations that began and developed to control medical therapies due to unethical human experiments. In addition, the chapter outlines India's drug and clinical trial regulatory systems development over the past decades, the new changes, and it is important to know these changes by researchers.

Published

2021-08-30

How to Cite

Vishal Vennu. (2021). The Drugs and Clinical Trial Rules: An Overview. India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers, 2–4. https://doi.org/10.9734/bpi/mono/978-93-91882-02-0/CH1

Issue

India’s New Drugs and Clinical Trial Rules: Perception and Perspectives of Indian Researchers

Section

Contents