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Midwest Regional Forum 2020 - Day 1
Date
September 9, 2020
Explore related products in the following collection:
CLINICAL (AND BEYOND) IN-USE STABILITY STUDIES – CHALLENGES, CONSIDERATIONS AND CASE STUDIES
Chairs
Abbvie, Inc.
Pfizer, Inc.
Speakers
Related Products
Regulatory Perspectives on In-use Storage of Biologic Products: Phase Appropriate Microbial Challenge Studies
A review of the regulatory requirements and guidance recommendations to support storage conditions of reconstituted and/or diluted drug products during IND development and for BLA approval will be presented. Microbial challenge study design and data analysis will be discussed…
