GOOD CLINICAL LABORATORY PRACTICE (GCLP): THE NEED FOR A HYBRID OF GOOD LABORATORY PRACTICE AND GOOD CLINICAL PRACTICE GUIDELINES/STANDARDS FOR MEDICAL TESTING LABORATORIES CONDUCTING CLINICAL TRIALS IN DEVELOPING COUNTRIES-Reference-Cited by-同舟云学术

GOOD CLINICAL LABORATORY PRACTICE (GCLP): THE NEED FOR A HYBRID OF GOOD LABORATORY PRACTICE AND GOOD CLINICAL PRACTICE GUIDELINES/STANDARDS FOR MEDICAL TESTING LABORATORIES CONDUCTING CLINICAL TRIALS IN DEVELOPING COUNTRIES

Published:2003-04 Issue:2 Volume:10 Page:83-89
ISSN:1052-9411
Container-title:Quality Assurance
language:en
Short-container-title:Quality Assurance

Author:

Stevens W.¹

Affiliation:

1. a Department of Molecular Medicine and Hematology, University of Witwatersrand and National Health Laboratory Service, Saxonwold, South Africa

Publisher

Informa UK Limited

Subject

General Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/10529410390262727

Reference6 articles.

1. ICH expert working group. ICH Topic E6 Guideline for Good Clinical Practice, ICH Harmonised Tripartite guideline (CPMP/ICH 135/95), EMEA status as of June (1996). http://www. emea.eu.int/

2. OECD principles of good laboratory practice in Annex II of the decision of the council concerning the mutual acceptance of data in the assessment of chemicals. (C(81)30 (final)). http://www. oecd.org/env/glp

3. UNDP/Worldbank/WHO. Good Laboratory Practice: Quality practices for regulated non-clinical research, http://www.who/int/tdr/publications/publications/

4. Stiles , T. Grant , V and Mawby , N. Good Clinical Laboratory Practice: A quality system for laboratories that undertake the analyses of samples from clinical trials, http://www.barqa.com/

5. Revised guidelines on ethics in medical research: General principles. MRC (2001). http:// sahealthinfo.org/ethicB/index

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