Pharmaceutical Equivalence of Topical Dosage Forms外用剂型的药物等价性.pptVIP

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Pharmaceutical Equivalence of Topical Dosage Forms外用剂型的药物等价性.ppt

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Pharmaceutical Equivalence of Topical Dosage Forms外用剂型的药物等价性

Quality by DesignforTopical Dosage Forms Robert Lionberger Office of Generic Drugs Therapeutic Equivalence Therapeutic Equivalents “have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling” Pharmaceutical Equivalents “(a)?contain identical amounts of the same active drug ingredient in the same dosage form and route of administration, and (b)?meet compendial or other applicable standards of strength, quality, purity, and identity” Bioequivalence “the rate and extent of absorption of the test drug do not show a significant difference from the rate and extent of absorption of the reference drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses “ Current Practice Pharmaceutical Equivalence + Bioequivalence = Therapeutic Equivalence Why Does Pharmaceutical Equivalence Matter? User experience and expectation Supports the conclusion of Therapeutic Equivalence based on a bioequivalence study Pharmacokinetic or pharmacodynamic bioequivalence studies in healthy subjects Extrapolation from a small group of healthy subjects to a broad patient population Clinical endpoint equivalence studies in patients Not sensitive to formulation differences Creams and ointments could be the same Extrapolating equivalence evaluated for one clinical indication to another The Future of Pharmaceutical Equivalence Current definition of Pharmaceutical Equivalence is the first step toward quality by design same drug, same strength, same dosage form 21st Century Paradigm Designed to be equivalent (Quality by Design) + Demonstrate bioequivalence (Verify by in vivo testing)= TE Ensure ANDA Quality Current Issues For topical products there are complex issues related to Pharmaceutical Equivalence A set of examples What differences in formulation are appropriate? Change of solvent hydrophilic or lipophilic base Water content Are two