Back to Agenda
Session 3: Bioequivalence and Quality Considerations for Inhalation and Nasal Drug-Device Combination Products
Session Chair(s)
Denise Conti, PhD, MSc
Senior Staff Fellow, Division of Therapeutic Performance, ORS, OGD, CDER
FDA, United States
Changning Guo, PhD
Research Chemist, Division of Complex Drug Analysis, OPQ, OTR, CDER
FDA, United States
This session will present an overview of oral inhalation and nasal drug-device combination products. We will discuss the current recommendations for establishing bioequivalence as described in product-specific guidances (PSGs), the remaining scientific gaps, and the use of new tools and approaches that can help to inform product development and support regulatory assessment. This session will also discuss relevant quality and manufacturing considerations for complex oral inhalation drug-device combination products, and the generic industry perspective on development and regulatory assessment.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand the scientific questions for development of complex oral inhalation and nasal drug-device generic combination products
- Discuss the recommendations and challenges to demonstrate pharmaceutical equivalence
- Understand the industry current practices and challenges for development
Speaker(s)
Overview of Complex Generic Inhalation and Nasal Drug-Device Combination Products
Bryan Newman, PhD
FDA, United States
Pharmacologist, Office of Generic Drugs, CDER
Quality Considerations for Complex Generic Inhalation Drug-Device Combination Products
Nashwa El-Gendy, PhD
FDA, United States
Staff Fellow, OPQ, OLDP, DIMRPIII, CDER
Manufacturing Considerations for Complex Generic Inhalation Drug-Device Combination Products
Joanne Wang, PhD
FDA, United States
Acting Branch Chief, OPMA, OPQ, CDER
Complex Generic Drug-Device Inhalation Products and User Interface Sameness: Successful Outcomes
Kimberly A. Witzmann, MD
FDA, United States
Acting Deputy Director, Office of Bioequivalence, Office of Generic Drugs, CDER
Pharmacokinetic Comparison of Locally Acting Nasal Suspension Spray Products
Guenther Hochhaus, PhD
University of Florida , United States
Professor
Pharmacokinetic Comparison of Locally Acting Nasal Suspension Spray Products
Jürgen B. Bulitta, PhD
University of Florida, United States
Professor, Department of Pharmacotherapy and Translational Research, UF College
Industry Perspective on Complex Generic Inhalation Drug-Device Combination Products
Xian-Ming Zeng, PhD, MS
Lupin Research, Inc., United States
EVP and Head of Global Inhalation and Complex Injectable R&D
Panel Discussion
All Session Speakers, United States
Have an account?