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Session 8B: Update on ICH M9 Gaps
Session Chair(s)
Roger Nosal, PHD
Vice President, Head of Global CMC, Pfizer Inc, United States
The development of biosimilars is increasing at a fast pace. This session will first look at the approvals granted so far in the US and EU for biosimilars as well as the current regulatory frameworks in these regions (eg guidance on interchangebility). Case studies will then address the obstacles for biosimilars in the CMC area and how these can be circumveted. In the end, CMC regulatory considerations for global development/ global regulatory submission will be discussed.
Speaker(s)
Jack Cook
Vice President, Clinical Pharmacology, Pfizer Inc., United States
Definition of Solubility (Maximum Therapeutic Dose vs. Highest Strength) and Requirement of Dose-Proportionality (Dose Exposure)
Mehul Mehta, PHD
Director, Division of Clinical Pharmacology, OCP, OTS, CDER, FDA, United States
Definition of Permeability (Relative Value of In Vitro Data)
Patrick J Marroum, PHD
Senior Research Fellow, AbbVie, United States
Dissolution and Formulation Criteria (Justification for Dissolution Criteria/Media; Excipient Impact on BA)
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