ICH Guidelines with Special Emphasis on Good Clinical Practice Guidelines (GCP)

Raghava Ramesh Narayana; KP Shivalinge Gowda; Syed Mansoor Ahamed and S Badami.

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)

Author(s): Raghava Ramesh Narayana, KP Shivalinge Gowda, Syed Mansoor Ahamed and S Badami.

Email(s): - ragpharma@gmail.com

DOI: Not Available

Address: Raghava Ramesh Narayana*, KP Shivalinge Gowda, Syed Mansoor Ahamed and S Badami
Department of Pharmacology, Sree Siddaganga College of Pharmacy, Tumkur. Karnataka.
*Corresponding Author

Published In: Volume - 2, Issue - 1, Year - 2010

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ABSTRACT:
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.

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Cite this article:
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.

Cite(Electronic):
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. Available on: https://rjppd.org/AbstractView.aspx?PID=2010-2-1-26