Abstract
The efficacy and safety of any pharmaceutical product is determined by the compounds (desired and undesired) which it contains. The purpose of quality control is to ensure that each dosage unit of the drug product delivers the same amount of active ingredients and is, as far as possible, free of impurities. As herbal medicinal products are complex mixtures which originate from biological sources, great efforts are necessary to guarantee a constant and adequate quality. By carefully selecting the plant material and a standardized manufacturing process the pattern and concentration of constituents of herbal medicinal products should be kept as constant as possible as this is a prerequisite for reproducible therapeutic results. With the increasing use of herbal products, particularly in the United States, the future worldwide labeling practice for herbal products should adequately address quality aspects.
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Busse, W. The Significance of Quality for Efficacy and Safety of Herbal Medicinal Products. Ther Innov Regul Sci 34, 15–23 (2000). https://doi.org/10.1177/009286150003400102
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DOI: https://doi.org/10.1177/009286150003400102