Making Sense of Excipient Performance for Quality by Design (QbD)

Event Date: April 19, 2012 at 10:00 AM EST

As the building blocks of drug products, knowledge of excipient performance is crucial to ensure robust formulation design and subsequent finished drug product quality. Insufficient understanding of excipient functionality and variability may result in costly delays to regulatory approval and manufacturing failures.

Integral to Quality by Design (QbD), an enhanced understanding of excipients for both new chemical entities (NCE’s) and generic pharmaceutical products is becoming a regulatory expectation. To support development, the US Pharmacopeia (USP) has issued a new informational chapter <1059> on excipient performance and test methods.

This webinar brings together experts from USP and the pharmaceutical industry to focus on current requirements and best practices for excipients, to better enable efficient development and manufacture of high quality drug products.


Angie Drakulich

Editorial Director
Pharmaceutical Technology


Catherine Sheehan

Director, Excipients
US Pharmacopeia

Ian Robertson
Global QbD Manager

Chris Moreton
Vice-President, Pharmaceutical Sciences
Finn Brit Consulting

Dr. Greg Amidon
Research Professor, Pharmaceutical Sciences
College of Pharmacy, University of Michigan, and
Chair of the USP Excipient Performance Expert Panel

Q&A Panel:

Dr. Lawrence Block

Professor of Pharmaceutics, Duquesne University, and
Chair, USP Monograph Committee

This is a FREE streaming audio Webcast and does not require a phone line. If you have any questions regarding this Webcast, please contact Jamie Carpenter,

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