Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines: 4. USING THE GUIDELINES: B. GUIDELINES FOR PHARMACODYNAMIC AND GENERAL PHARMACOLOGICAL STUDIES OF HERBAL MEDICINES: ADMINISTRATION

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

ADMINISTRATION

Route of administration

Since oral dosage forms of herbal medicines are usually used clinically, the oral route of administration is ordinarily the most suitable for use with test animals. Additional routes may be used to approximate the intended route of administration in man.

Frequency of administration

Ordinarily, doses selected for a study should be established by means of a dose-response relationship but since such relationships often cannot be demonstrated with herbal medicines in whole animals, it may be sufficient to select one or more doses that provide a desired effect.

Selection of doses for animal studies should be in accordance with customary clinical doses.

Control group

It is essential that all studies include a negative (vehicle only) control group of animals and, if possible, a positive control group, that is, a group of animals in which the effect of a drug known to be positive is examined.