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One of Johns Hopkins University First Female Scientists

  • Approval of botanical NDAs is possible

  • A practical approach for quality control of botanical products can be developed

  • ​Raw material controls required

  • Clinically relevant specifications for drug substance/product can be established if multiple batches are used in the pivotal clinical trials

  • Other data, e.g., from bioassay and/or multiple-batch, and from dose response clinical trials, may be needed in conjunction with conventional CMC data, to help ensure therapeutic consistency

  • Clinical trials of botanical drugs are no more difficult than non-botanical drugs


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