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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)
Anthony Hickey
Distinguished Fellow, RTI International, United States
Impact of Orally Inhaled Drug Product Design Complexity on Quality and Performance
Kimberly A. Witzmann, MD
Acting Deputy Director, Office of Bioequivalence, Office of Generic Drugs, CDER, FDA, United States
User Interface Considerations on Bioequivalence and Therapeutic Equivalence for Complex Generic Orally-Inhaled, Nasal, and Auto-Injector Drug Products
Denise Conti, PhD, MSc
Senior Staff Fellow, Division of Therapeutic Performance, ORS, OGD, CDER, FDA, United States
Overview of Complex Generic Inhalation and Auto-Injector Drug-Device Combination Products
Guenther Hochhaus, PhD
Professor, University of Florida, United States
Pharmacokinetic Comparison of Locally-Acting Dry Powder Inhalers
Jürgen B. Bulitta, PhD
Professor, Department of Pharmacotherapy and Translational Research, UF College , University of Florida, United States
Pharmacokinetic Comparison of Locally-Acting Dry Powder Inhalers
Jason D. Rodriguez, PhD
Division Director, CDER/OPQ/OTR/Division of Complex Drug Analysis, FDA, United States
Enhanced Analytical Tools for Bioequivalence Evaluation of Nasal Spray Drug Products
Carol Kim
Acting Team Lead, Division of Clinical Review,Office of Bioequivalence,OGD, CDER, FDA, United States
Clinical Considerations for the Design and Conduct of Comparative Clinical Endpoint Studies for Establishing Bioequivalence of Inhalation and Nasal Drug Products
Sarah Yim, MD
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, FDA, United States
Clinical Considerations for the Design and Conduct of Comparative Clinical Endpoint Studies for Establishing Bioequivalence of Inhalation and Nasal Drug Products
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