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)
Considerations for Additional Strength Waivers of MR Products
James E. Polli, PhD
Co-Director, CRCG
Professor, University of Maryland
Unlocking Strength Scaling for Extended-Release Tablet Development: Research Gaps and Opportunities
Jie Shen, PhD
Associate Professor of Pharmaceutical Sciences, Northeastern University
Advancing Generic MR Product Development Using Tiny-TIMsg to Predict In Vivo Performance
Lieke van den Elsen, PhD
Scientific Advisor, InnoGI Technologies
Criteria to Decide Whether pAUCs Are Appropriate BE Metrics and Alternatives When They Are Not
Charles E. DiLiberti, MS
President, Montclair Bioequivalence Services, LLC
Opportunities and Challenges with IR/MR Dosage Forms in Lipid-Based Formulations
Karunakar (Karu) Sukuru, RPh, PhD
Global VP, Pharma Product Development
Catalent Pharma Solutions
Quality Control of 3D Printed Controlled Release Dosage Forms in Distributed Manufacturing Networks
Stephen Hoag, PhD
Professor, University of Maryland at Baltimore
Abstract
The session “Challenges and Opportunities for Modified Release Generic Products” addresses critical aspects of developing generic modified-release (MR) drug products. Presenters delve into scientific considerations for bioequivalence (BE) waiver approaches, covering additional strengths and the use of advanced in vitro and in silico models. James Polli discusses the complexities of proportionality for strength waivers, noting that even minor deviations in factors like dissolution similarity lead to conservative views on waivers. Jie Shen explores strength scaling for extended-release tablets, showing that compositional variations can still achieve similar dissolution if critical polymer parameters are controlled, and advocates for new imaging and predictive dissolution tools. Lieke van den Elsen presents the TinyTIM system, a dynamic GI model predicting in vivo performance under varied conditions, including food effects and pediatric scenarios, suggesting its potential to reduce some clinical BE studies. Charles DiLiberti critiques partial AUCs, proposing time-based metrics to better control drug onset and offset. Karunakar Sukuru highlights challenges and opportunities with lipid-based formulations (LBFs), emphasizing the need for discriminatory dissolution methods and updated IVIVC guidelines to account for LBF complexities. Stephen Hoag introduces 3D printing for MR dosage forms, showcasing its customization potential and outlining research needs for material science and quality control. The session collectively emphasizes ongoing research to support harmonization of MR product recommendations.