The importance of method validation in herbal drug research

Abstract

There are countless scientific publications on herbal drugs, but unfortunately many of them do not correctly report their chemical, biological and pharmacological aspects, including the composition and stability of the herbal/extract preparations, therefore their safety, efficacy and consistency could not be proven. For developing a modern drug from herbal drug(s), complete chemical and pharmacological characterizations of their bioactive metabolites need to be well established. Reproducible results require the development, assessment, and standardization of the chemical, biological and pharmacological methods based on the current state of the art. Therefore, all methods used in research must be properly validated before its routine applications. This present review will describe and discuss the important aspects of method validation (chemical, biological and pharmacological) in herbal drug research according to the newest current Pharmacopeia, official Guidelines and related recent publications.

Keywords: Bioassay; Chemical profiling; Herbal drugs; Quality active marker; Quality assessment; Validation of the method.