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Session 2: Bioequivalence Considerations for Complex Generic Inhalation, Nasal, and Auto-Injector Drug-Device Combination Products
Session Chair(s)
Kimberly A. Witzmann, MD
Acting Deputy Director, Office of Bioequivalence, Office of Generic Drugs, CDER
FDA, United States
This session will present an overview of complex orally inhaled and nasal drug products (OINDPs) as well as complex auto-injector drug-device combination products. We will discuss the current recommendations for establishing bioequivalence as described in product-specific guidances (PSGs), the remaining scientific questions and challenges, and how new tools and innovations can help to inform product development and support the regulatory assessment process, with the goal of increasing access to safe, affordable generic drugs for the American public.
Learning Objective :
Speaker(s)
Impact of Orally Inhaled Drug Product Design Complexity on Quality and Performance
Anthony Hickey
RTI International, United States
Distinguished Fellow
User Interface Considerations on Bioequivalence and Therapeutic Equivalence for Complex Generic Orally-Inhaled, Nasal, and Auto-Injector Drug Products
Kimberly A. Witzmann, MD
FDA, United States
Acting Deputy Director, Office of Bioequivalence, Office of Generic Drugs, CDER
Overview of Complex Generic Inhalation and Auto-Injector Drug-Device Combination Products
Denise Conti, PhD, MSc
FDA, United States
Senior Staff Fellow, Division of Therapeutic Performance, ORS, OGD, CDER
Pharmacokinetic Comparison of Locally-Acting Dry Powder Inhalers
Guenther Hochhaus, PhD
University of Florida, United States
Professor
Pharmacokinetic Comparison of Locally-Acting Dry Powder Inhalers
Jürgen B. Bulitta, PhD
University of Florida, United States
Professor, Department of Pharmacotherapy and Translational Research, UF College
Enhanced Analytical Tools for Bioequivalence Evaluation of Nasal Spray Drug Products
Jason D. Rodriguez, PhD
FDA, United States
Division Director, CDER/OPQ/OTR/Division of Complex Drug Analysis
Clinical Considerations for the Design and Conduct of Comparative Clinical Endpoint Studies for Establishing Bioequivalence of Inhalation and Nasal Drug Products
Carol Kim
FDA, United States
Acting Team Lead, Division of Clinical Review,Office of Bioequivalence,OGD, CDER
Clinical Considerations for the Design and Conduct of Comparative Clinical Endpoint Studies for Establishing Bioequivalence of Inhalation and Nasal Drug Products
Sarah Yim, MD
FDA, United States
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER