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1 v/v omacetaxine 0. 025 0. 25 1 2. 5 or 25 M or one of three accepted positive controls human CYP inducers2 on cytochrome P450 CYP enzymes CYP1A2 CYP2B6 and CYP3A4 activity. CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER 203585Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW S OFFICE OF CLINICAL PHARMACOLOGY PHARMACOMETRIC REVIEW NDA 203585 Submission Date Generic Name Omacetaxine mepesuccinate Reviewer Jee Eun Lee Ph. Table 3. Objective Function Values for Base and...

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