Refine your search
Collections
Co-Authors
Year
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z All
Ramesh Narayana, Raghava
- ICH Guidelines with Special Emphasis on Good Clinical Practice Guidelines (GCP)
Abstract Views :196 |
PDF Views:0
Authors
Affiliations
1 Department of Pharmacology, Sree Siddaganga College of Pharmacy, Tumkur, Karnataka, IN
1 Department of Pharmacology, Sree Siddaganga College of Pharmacy, Tumkur, Karnataka, IN
Source
Research Journal of Pharmacology and Pharmacodynamics, Vol 2, No 1 (2010), Pagination: 27-32Abstract
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.Keywords
ICH, Good Clinical Practices Guidelines, Quality, Safety, Efficacy and Multidisciplinary.
References
- Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. Annex 3 of The Use of Essential Drugs Sixth report of the WHO, Expert Committee. Geneva. World Health Organization, 1995: 97-137.
- ASCO outlines minimum standards and exemplary attributes for research sites: Previews tools to be provided. J Oncol Pract 4:185-187.
- Singh S. International Conference on Harmonisation an update. The eastern Pharmacist. 1998:61:42-43.
- Artiges A, Sheinen E, Potter C, Tanimoto T, editors. Pharmacopoeial Harmonisation. Proceedings of the 6th International Conference on Harmonisation. 2003, Nov 12-15; Osaka, Japan.
- Yetter R, editor. Partnership in Harmonisation. Proceedings of the 6th International Conference on Harmonisation. 2003, Nov 12-15; Osaka, Japan.
- Amitava Roy, A Ghosh, the sixth international conference on hormonisation (ICH6)-A Promising Future in Global Pharmaceutical Industry, Research J.Pharm.and Tech. I (3): July-Sept.2008 pg no.161-165.
- S.D. Seth, Madhu khanna, Hand Book of Good Clinical Practice (GCP): Guidance for implementation, Indian J Med Res 125, May 2007, pp 701-704.
- Council for International Organizations of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, CIOMS, 1993, Annex 1.
- Christley HM. (1998) Conducting Clinical Trials in South Africa. Applied Clinical Trials. September 7(9) 56-59.
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (1996) ICH Tripartite Guideline. Guideline for Good Clinical Practice. Recommended for Adoption at Step 4 of the ICH Process on 1 May 1996 by the ICH Steering Committee.
- Malaysian Guidelines for Good Clinical Practice. 2nd edition. Ministry of Health Malaysia, 2004.
- European Medicines Agency. ICH Harmonised Tripartite Guideline E6: Note for Guidance on Good Clinical Practice (PMP/ICH/135/95). London: European Medicines Agency, 2002.
- A Vijayananthan, O Nawawi, The importance of Good Clinical Practice guidelines and its role in clinical trials, Biomed Imaging Interv J 2008; 4(1):e5, pg no.1-4.
- The World Medical Association. Declaration of Helsinki [Web Page]. 2004; Available at http://www.wma.net/e/policy/b3.htm.