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World Health Organization : Year 2005 ; The Special Programme for Research and Training in Tropical Diseases, Geneva Guidance, No. 05.1 - in English: Operational Guidance ; Information Needed to Support Clinical Trials of Herbal Products

By World Health Organization

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Book Id: WPLBN0000180482
Format Type: PDF eBook
File Size: 0.3 MB
Reproduction Date: 2005

Title: World Health Organization : Year 2005 ; The Special Programme for Research and Training in Tropical Diseases, Geneva Guidance, No. 05.1 - in English: Operational Guidance ; Information Needed to Support Clinical Trials of Herbal Products  
Author: World Health Organization
Volume:
Language: English
Subject: Health., Public health, Wellness programs
Collections: Medical Library Collection, World Health Collection
Historic
Publication Date:
Publisher: World Health Organization

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Organization, W. H. (n.d.). World Health Organization : Year 2005 ; The Special Programme for Research and Training in Tropical Diseases, Geneva Guidance, No. 05.1 - in English. Retrieved from http://www.nationalpubliclibrary.info/


Description
Medical Reference Publication

Excerpt
1. | INTRODUCTION Herbal and other traditional pharmacologic therapies are in widespread use throughout the world. Such widespread use suggests, but does not assure, that traditional medicines have a favourable risk-benefit ratio. Rather, traditional medicines may be regarded as a rich source of potentially attractive therapies. The actual benefits and risks remain to be evaluated by clinical trials supported and conducted according to the principles of modern clinical science.

Table of Contents
CONTENTS 1. | INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2. | CHEMISTRY-MANUFACTURING-CONTROL (CMC) CONSIDERATIONS FOR HERBAL PRODUCTS . . . . . . . . . . . . . . . . 4 2.1. Overview of CMC evidence needed to support clinical trials for herbal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2.2. Information needed to support a clinical trial for a herbal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2.3. Information on herbal product proposed for phase 3 studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 3. | NON-CLINICAL CONSIDERATIONS FOR HERBAL PRODUCTS 3.1. Introduction: Information needed for a conventional drug . . . . . . . . . 7 3.2. Information needed to support a clinical trial for a herbal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4. | CLINICAL CONSIDERATIONS FOR HERBAL PRODUCTS 4.1. Introduction: Information needed for a standard intervention . . . . . . 9 4.2. Information needed to support phase 2 trials . . . . . . . . . . . . . . . . . . . 10 4.3. Information needed to support phase 3 trials . . . . . . . . . . . . . . . . . . . 11 5. | ETHICAL CONSIDERATIONS IN CLINICAL TRIALS WITH HERBAL PRODUCTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 APPENDIX 1 List of contributors to this document . . . . . . . . . . . . . . . . . . . . . . . . 14 APPENDIX 2 Glossary of key terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

 

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