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Patient Centric Dissolution Testing: Biopharmaceutics Risk Framework

Tuesday, November 9, 2021

12:00 p.m. - 1:30 p.m.

Biopharmaceutics Risk Assessment focuses on the evaluation of BA/BE impact attributed to physico-chemical and biopharmaceutics properties of the drug substance and the control strategy for the drug product. With the power of predictive dissolution, the impact of critical material attributes and critical process parameters on the in vivo performance can be quantitatively assessed to provide a scientific and risk-based knowledge platform that will support the establishment of patient-centric quality standards. Dissolution/drug release specifications (method and acceptance criteria) that provides predictive insight to in vivo performance is a powerful tool in ensuring high quality drug products throughout the product life cycle.

This session will discuss how FDA and the generics industry can work together to explore pathways to achieve the same shared goals of increasing access to quality generic medicines to America’s patients, including implementation of the ICH M9 BCS guidance.

Moderator: Elisabeth Kovacs
Chief Executive Officer, EK Consulting

Emilija Fredro-Kumbaradzi, PhD
Associate Director, Biowaivers, Biocorrection, and Statistical Support, Apotex Inc.

Kimberly Raines, PhD
Branch Chief, Division of Biopharmaceutics, Office of New Drug Products, OPQ, CDER, FDA

Diana Vivian, PhD 
Acting Associate Director, Division of Bioequivalence II, OB, OGD, CDER, FDA

Ilan Zalit
Manager of Pharmaceutical Research Group, Teva Pharmaceuticals

Liang Zhao, PhD
Director, Division of Quantitative Methods & Modeling, ORS, OGD, CDER, FDA

Utpal Munshi, PhD 
Acting Director, Division of Bioequivalence I, OB, OGD, CDER, FDA

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