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BOTANICAL DRUG CHARACTERISTICS


One of Johns Hopkins University First Female Scientists

  • Botanical drugs are heterogeneous mixtures that contain:

  • Multiple chemical components

  • Potentially more than one chemical component that contributes meaningfully to the mixture’s physiological or pharmacological action

  • Chemical components in a botanical mixture and their biological activities are generally not well characterized.

  • Botanical drugs exhibit batch-to-batch variations in properties (e.g., chemical composition).

  • ​Natural variability at the plant and raw material levels

  • Greater than the variability typically observed in non-botanical drugs (e.g., chemically synthesized and purified drug molecules)

  • Many botanical drug candidates have previous human-use experience.

  • Dietary supplements in the U.S.

  • Herbal medicines (e.g., Europe)

  • Traditional medicines (e.g., China)

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