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Bioequivalence of Inhalation Drug Products: Challenges and Opportunities

Bioequivalence of Inhalation Drug Products: Challenges and Opportunities. Lawrence X. Yu, Ph.D. Director for Science Office of Generic Drugs, OPS, CDER Food and Drug Administration. Advisory Committee for Pharmaceutical Science and Clinical Pharmacology 23 July 2008.

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Bioequivalence of Inhalation Drug Products: Challenges and Opportunities

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  1. Bioequivalence of Inhalation Drug Products: Challenges and Opportunities Lawrence X. Yu, Ph.D. Director for Science Office of Generic Drugs, OPS, CDER Food and Drug Administration Advisory Committee for Pharmaceutical Science and Clinical Pharmacology 23 July 2008

  2. FDA Critical PathMay 2007 • Four Areas of Opportunity for Generic Drugs • Improve the science underlying quality by design for the development and manufacture of generic drug products • Improve the efficiency of current methods for assessment of bioequivalence of systemically acting drugs • Develop methods for the assessment of bioequivalence of locally acting drugs • Develop methods for characterizing complex drug substances and products http://www.fda.gov/oc/initiatives/criticalpath/reports/generic.html

  3. Dose to Patient Lung Deposition Systemic Circulation Liver GI Tract Systemic vs Inhalation Drugs

  4. Factors Affecting Respiratory Drug Delivery Physicochemical Properties of Drug Substance Formulation Local Drug Delivery in the Respiratory Tract Patients Device

  5. Establishment of Bioequivalence for Inhalation Products Formulation Device Shape and Design In Vitro BE Studies (e.g. aerodynamic particle size) Bioequivalence Comparative Systemic Exposure Studies In Vivo Studies with Clinical or Pharmacodynamic Endpoints

  6. Inhaled Corticosteriods and PD endpoints • Inhaled Corticosteriods • Fluticasone Propionate • Beclomethasone Dipropionate • Mometasone Furoate • Others • PD Endpoints • Forced expiratory volume in 1 second (FEV1) • Exhaled nitric oxide (eNO) • Others

  7. Use of Inhaled Corticosteroid Dose- Response as a Means to Establish Bioequivalence of Inhalation Drug Products • Asthma Stability Model for Inhaled Corticosteroid Dose-response Wallace P. Adams, Ph.D. • Exhaled Nitric Oxide Study Model for Inhaled Corticosteroid Dose-response Badrul A. Chowdhury, M.D., Ph.D.

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