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Research Journal of Pharmacology and Pharmacodynamics
ISSN: 2321-5836(Online), 0975-4407(Print)
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ICH Guidelines with Special Emphasis on Good Clinical Practice Guidelines (GCP)
Raghava Ramesh Narayana
KP Shivalinge Gowda
Syed Mansoor Ahamed and S Badami.
Raghava Ramesh Narayana*, KP Shivalinge Gowda, Syed Mansoor Ahamed and S Badami
Department of Pharmacology, Sree Siddaganga College of Pharmacy, Tumkur. Karnataka.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights.
ICH, Good clinical practices guidelines, Quality, Safety, Efficacy and Multidisciplinary
Raghava Ramesh Narayana, KP Shivalinge Gowda, Syed Mansoor Ahamed and S Badami. ICH Guidelines with Special Emphasis on Good Clinical Practice Guidelines (GCP). Research J. Pharmacology and Pharmacodynamics. 2010; 2(1):27-32.
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