Abstract
Preclinical and clinical development of herbal drugs should follow science-based principles. The presence of numerous constituents in herbal extracts requires an intelligent screening model that can guide the development of specific extracts.
The strategy developed in our laboratories to characterize and standardize therapeutically meaningful extracts can be described as an activity-guided fractionation and testing procedure which can ultimately lead to the discrimination of active constituents. Extracts should be standardized in order to provide batch conformity over time, leading to equipotent formulations at the end. If markers are used for standardization, preference should be given to pharmacologically-active principles relevant to the indication in which the final drug is used.
Drug formulations based on rationally developed extracts need to be documented in well-controlled clinical trials with relevant outcome measurements. The clinical studies should be planned according to the indication investigated, though no specific design is needed for herbal drugs in comparison to chemically defined entities. Modern herbal drugs can be developed and documented in a way leading to a broader acceptance by the scientific community.
This paper provides examples which prove that this development strategy can be applied successfully.
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