Back to: FDA Generic Drug Science and Research Initiatives Public Workshop 2025
Presenters
Introduction
Dongmei Lu, PhD
Associate Director, Division of Therapeutic Performance II (DTP II)
Office of Regulatory Science (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Nilufer Tampal, PhD
Associate Director, Office of Bioequivalence (OB)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Amorphous Solid Dispersion (ASD) Products and Potential Alternative BE Approaches
Girish Nihalani, MS
Associate Director, Product Development
Hikma Pharmaceuticals USA Inc.
Dissolution of Amorphous Solid Dispersions and Absorption of Poorly Soluble Drugs
Geoff G. Z. Zhang, PhD
FAAPS Founder
Chief Technical Director, ProPhysPharm LLC
Modeling & Simulation Tools as Alt. BE Approaches for BCS IV & High-Risk Prods: Generic Industry Perspective
Sivacharan Kollipara, MS
Head, Biopharmaceutics
Dr. Reddy’s Laboratories Ltd., India
Advancing IVIVC in Lipid-Based Formulations: Addressing In Vitro Dissolution Challenges for BA Correlations
Sandip Tiwari, PhD
Head of Technical Services, Pharma Solutions, NA
BASF Corporation
Enhancing Patient BE Studies Using Model-Integrated Evidence (MIE)
Yuqing Gong, PhD
Senior Pharmacologist, 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)
Abstract
This session, “Implementation of the M13A Guidance: Lessons Learned and Advances for Immediate Release Products,” explores challenges and advancements in bioequivalence (BE) for complex generic drug products following the M13A guidance. Presenters discuss high-risk formulations like Amorphous Solid Dispersions (ASDs) and Lipid-Based Formulations (LBFs), which often require both fasting and fed BE studies due to their dynamic behavior and variable food effects. Discussions highlight the inherent complexity of ASDs, their dissolution mechanisms, and the importance of factors like excipients and nanoparticle stability. For LBFs, standard in vitro dissolution methods often lack discriminatory power, prompting exploration of advanced tools like the PIONS µFLUX method, which integrates dissolution and permeability to better correlate with in vivo performance. A significant focus is placed on the utility of modeling and simulation tools, particularly Physiologically Based Biopharmaceutics Modeling (PBBM) and Physiologically Based Pharmacokinetic (PBPK) models, as alternative BE approaches to potentially waive certain clinical studies. Model-Integrated Evidence (MIE) is also presented as a powerful tool to enhance efficiency and feasibility in patient BE studies, supporting sparse sampling designs and alternative crossover studies without washout, addressing challenges in these complex clinical settings. The session emphasizes the ongoing research and regulatory considerations for widespread adoption of these advanced methods.