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Good Clinical Laboratory Practice

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H A N D B O O K - WHO

H A N D B O O K - WHO

www.who.int

H A N D B O O K GOOD LABORATORY PRACTICE (GLP) Quality practices for regulated non-clinical research and development Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by

  Good, Practices, Laboratory, Clinical, H a n d b o o k, H a n d b o o k good laboratory practice

GOOD CLINICAL LABORATORY PRACTICE (GCLP)

GOOD CLINICAL LABORATORY PRACTICE (GCLP)

www.who.int

2 | Good Clinical Laboratory Practice (GCLP)/08 FOREWORD For some years, it has been internationally recognized that clinical laboratories processing specimens from clinical trials require an appropriate set of standards

  Good, Practices, Laboratory, Clinical, Good clinical laboratory practice

GUIDELINE FOR GOOD CLINICAL PRACTICE

GUIDELINE FOR GOOD CLINICAL PRACTICE

www.ich.org

GUIDELINE FOR GOOD CLINICAL PRACTICE INTRODUCTION Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the

  Good, Practices, Clinical, Good clinical practice

South African good clinical practice guidelines. …

South African good clinical practice guidelines. …

www.kznhealth.gov.za

SOUTH AFRICAN GOOD CLINICAL PRACTICE GUIDELINES SECOND EDITION Suggested Citation: Department of Health, 2006. Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa.

  Guidelines, Good, Practices, Clinical, Good practices, South, African, South african good clinical practice guidelines

Guideline for good clinical practice E6(R2)

Guideline for good clinical practice E6(R2)

www.ema.europa.eu

Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/70 Document History First Codification History Date New Codification

  Good, Practices, Clinical, Good clinical practice

Guideline for good clinical practice E6(R2)

Guideline for good clinical practice E6(R2)

www.ema.europa.eu

Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/75 10 Document History 11 First Codification History Date New Codification November

  Guidelines, Good, Practices, Clinical, Good clinical practice e6

ICH Topic E 6 (R1) Guideline for Good Clinical …

ICH Topic E 6 (R1) Guideline for Good Clinical

www.pdexternal-roche.com

ICH Topic E 6 (R1) Guideline for Good Clinical Practice 1. GLOSSARY 1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly

  Guidelines, Good, Practices, Clinical, Guideline for good clinical, Guideline for good clinical practice

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