Back to: FDA Generic Drug Science and Research Initiatives Public Workshop 2025
Presenters
Introduction
Bryan Newman, PhD
Lead Pharmacologist, Division of Therapeutic Performance I (DTP I)
Office of Regulatory Science (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Ahmed Zidan, PhD
Senior Research Pharmacologist
Division of Product Quality and Research V (DPQR V)
Office of Pharmaceutical Quality Research (OPQR)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Challenges with Method Standardization for Inhalation and Nasal Drug Products
Susan Boc, PhD
Pharmacokineticist, Division of Therapeutic Performance I (DTP I)
Office of Regulatory Science (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Biopredictive In Vitro Characterization to Correlate Quality Attributers to In Vivo Performance
Hailing Zhang, PhD
Division Director, Division of Product Quality Assessment XII (DPQA XII),
Office of Product Quality Assessment II (OPQA II)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Advancing In Silico Methods & Understanding the Impact of Compositional Differences on Performance
Ross Walenga, PhD
Senior Chemical Engineer
Division of Quantitative Methods and Modeling (DQMM)
Office of Regulatory Science (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Research Opportunities to Support Further PSG Development for Orally Inhaled Products
Andrew Cooper, PhD
Sr. Director, Development for In-Vitro Performance Lead
Viatris Inc.
Enhanced PBPK-Based IVIVE Method to Support the Development of Pulmonary Drug Products
Maxime Le Merdy, PhD
Director, PBPK Research and Collaboration
Simulations Plus
Microstructural Techniques for Demonstrating Bioequivalence in Dry Powder Inhalers
Nuria Manzano Jurado, BSc
Specialist, R&D Pharma Services
Nanopharm
Application of Mechanistic PBPK Modeling to Understand Drug Release from PLGA-Based Solid Implants
Naresh Mittapelly, PhD
Research Scientist II, Certara UK Ltd
United Kingdom
The Utility of In Silico Modelling and Substitution Risk for Generic Orally Inhaled Drugs
Clare Butler, BSc, PhD
Principal Product Development Scientist, Respiratory R&D
Teva Pharma
Abstract
This session explores the evolving strategies for demonstrating bioequivalence of complex generic drug products, specifically focusing on locally acting inhalation and nasal formulations. Presenters discuss the shift in product-specific guidances towards alternative options for bioequivalence demonstration, moving beyond traditional comparative clinical studies. Significant attention is given to the ongoing challenges in standardizing and implementing these alternative in vitro studies, including dissolution, realistic aerodynamic particle size distribution (APSD), and comparative characterization. The importance of biopredictive in vitro characterization for establishing patient-centric quality standards and linking quality attributes to in vivo performance is highlighted. Mechanistic modeling approaches, such as PBPK and CFD models, are presented as valuable tools for understanding the impact of compositional differences and predicting drug behavior. Industry insights reveal opportunities for more efficient generic development while also identifying research gaps in validating new in vitro tests, leveraging pharmacokinetic data for regional deposition assessment, and applying microstructural techniques for Q3 equivalence. The session underscores the need for continued research to refine these advanced methods, address remaining scientific gaps, and ultimately expedite patient access to quality generic products.