Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines: BIBLIOGRAPHY

Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
(1993; 94 pages)

Table of Contents

FOREWORD
1. INTRODUCTION
	BACKGROUND
	GOALS
	OBJECTIVES
	DEFINITION OF TERMS
2. GENERAL CONSIDERATIONS IN HERBAL MEDICINE RESEARCH
	LEGAL CONSIDERATIONS
	ETHICAL CONSIDERATIONS
		RESEARCH ON HUMAN SUBJECTS
		RESEARCH ON ANIMALS
		RESPECT FOR THE ENVIRONMENT
	TRADITIONAL KNOWLEDGE ON HERBAL MEDICINE
	REGULATORY REQUIREMENTS
	PURPOSES OF RESEARCH
	SELECTION OF RESEARCH PROJECTS
	RESEARCH APPROACHES
	ASSURING ACCESS TO RELEVANT DATABASES
	EDUCATION
3. RESEARCH STUDIES
	LITERATURE BACKGROUND
	PROTOCOL PREPARATION
	QUALITY SPECIFICATIONS OF PLANT MATERIALS AND PREPARATION
	NON-CLINICAL STUDIES
		PHARMACODYNAMIC INVESTIGATIONS
		GENERAL PHARMACOLOGICAL INVESTIGATIONS
		TOXICOLOGICAL INVESTIGATIONS
		METHODS
	CLINICAL TRIALS USING HERBAL MEDICINES
		CLINICAL TRIAL PROTOCOL DEVELOPMENT
		PHASES OF A CLINICAL TRIAL
		ETHICS REVIEW BOARD
		RESPONSIBILITIES OF INVESTIGATORS
		RESPONSIBILITIES OF THE SPONSOR
		DATA MANAGEMENT
		STATISTICAL ANALYSIS
		REPORTING
	EVALUATION OF HERBAL MEDICINE RESEARCH
	TECHNOLOGY TRANSFER AND EDUCATION
		HERBAL MEDICAL RESEARCH
		THE HEALTH CARE PROFESSIONS
		THE PUBLIC
4. USING THE GUIDELINES
	A. GUIDELINES FOR QUALITY SPECIFICATIONS OF PLANT MATERIALS AND PREPARATIONS
		INFORMATION FOR FRESH, DRIED AND PROCESSED PLANT MATERIALS
		INFORMATION FOR MEDICINAL PREPARATIONS OF PLANT MATERIALS
	B. GUIDELINES FOR PHARMACODYNAMIC AND GENERAL PHARMACOLOGICAL STUDIES OF HERBAL MEDICINES
		ANIMALS
		ADMINISTRATION
	C. GUIDELINES FOR TOXICITY INVESTIGATION OF HERBAL MEDICINES
		ACUTE TOXICITY TEST
		LONG-TERM TOXICITY TEST
		LOCAL TOXICITY TEST
		SPECIAL TOXICITY TESTS
ANNEXES
	ANNEX 1. WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI*
	ANNEX 2. REPORT OF THE MEETING OF THE WORKING GROUP ON THE SAFETY AND EFFICACY OF HERBAL MEDICINE (MANILA, 5 - 9 OCTOBER 1992)
	ANNEX 3. LIST OF MEMBERS, CONSULTANTS AND SECRETARIAT
NOTES
BIBLIOGRAPHY
SELECTED WHO PUBLICATIONS OF RELATED INTEREST

BIBLIOGRAPHY

Guidelines for the assessment of herbal medicine programme on traditional medicine. Geneva: World Health Organization, document, 1991 (WHO/TRM/91.4).

Guidelines for reproduction studies for safety evaluation of drugs for human use. Bethesda, MD: U.S. Food and Drug Administration, 1966.

1990 Guidelines for toxicity studies of drugs manual/editorial supervision by New Drugs Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare. Tokyo: Yakuji Nippo, 1991.

Guiding principles for clinical research on new drugs (traditional Chinese medicine). Beijing, China: Ministry of Public Health; Bureau of Drug Policy and Administration, 1989.

Proposed WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products WHO drug information 1992. 6(4) 170-188

Provisions for new drugs approval Beijing, China Ministry of Public Health, 1988.

Provisions for new drug approval: supplementary stipulation and revision of issues related to traditional Chinese medicine, Beijing, China: Ministry of Public Health, 1992.

Selection and scientific validation of medicinal plants for primary health care. Taguig, Metro Manila: Department of Science and Technology, Philippine Council for Health Research and Development, 1991. (Technical report series 12).

Technical guidelines for pharmaceuticals in the European Economic Community, editor, Duilio Poggiolini, New York: Raven Press, 1983.

The rules governing medicinal products in the European community: Volume III. Guidelines on the quality, safety and efficacy of medicinal products for human use, Luxembourg: Office for Official Publications of the European Communities, 1989.