Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines

Sets out detailed guidelines for conducting scientific research on the safety and efficacy of herbal medicines. The guidelines which reflect the consensus reached by 17 experts in pharmacology biochemistry and traditional medicine respond to the need to assure the safety of widely-used herbal medicines while also facilitating the search for new pharmaceutical products. Specific research criteria are covered together with general principles of investigation including ethical concerns.

The book has three parts. The first discusses the special properties of herbal medicines that need to be considered when designing research protocols. The second part provides detailed guidance on the objectives of research the contents of a research protocol and the methods of investigation for non-clinical studies and for Phase I to Phase IV clinical trials.

The third part which forms the core of the book presents three sets of research guidelines: for quality specifications of plant materials and preparations for pharmacodynamic and general pharmacological studies of herbal medicines and for toxicity investigation of herbal medicines. Topics covered range from the information required to establish the identity and quality of plant materials or preparations through the selection of appropriate test systems for pharmacodynamic studies to detailed advice on the many different tests examinations observations and experimental procedures required in experimental animals and controls to establish the safety of herbal medicines.

The guidelines are intended to facilitate the work of research scientists and clinicians while also furnishing some reference points for the governmental industrial and non-profit organizations providing financial support.