期刊
JOURNAL OF MEDICINAL CHEMISTRY
卷 58, 期 21, 页码 8360-8372出版社
AMER CHEMICAL SOC
DOI: 10.1021/acs.jmedchem.5b00417
关键词
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资金
- NIH Office of Dietary Supplements [P50 AT000155]
- National Center for Complementary and Integrative Health
Regulated differently than drugs or foods, the market for botanical dietary supplements continues to grow worldwide. The recently implemented U.S. FDA regulation that all botanical dietary supplements must be produced using good manufacturing practice is an important step toward enhancing the safety of these products, but additional safeguards could be implemented, and unlike drugs, there are currently no efficacy requirements. To ensure a safe and effective product, botanical dietary supplements should be developed in a manner analogous to pharmaceuticals that involves identification of mechanisms of action and active constituents, chemical standardization based on the active compounds, biological standardization based on pharmacological activity, preclinical evaluation of toxicity and potential for drug-botanical interactions, metabolism of active compounds, and finally, clinical studies of safety and efficacy. Completing these steps will enable the translation of botanicals from the field to safe human use as dietary supplements.
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