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Product Stability Testing in Biologics
2022-03-16
Stability testing is an important aspect of product development and is carried out throughout the life cycle of a product. Stability is part of a biotherapeutic's quality desired product profile, and the results help analysts understand how temperature, relative humidity (RH), light, storage, pH, and other factors affect critical quality attributes (CQAs) of both medicinal ingredients and products.
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PK/PD in Drug Discovery and Development MasterClass - US edition
14-17 May, 2024
Understand the values of PK/PD studies in drug R&D from an industrial perspective
learn more >>Quality Content (ICH M4Q) of the Common Technical Document (CTD) for New Biotechnological Entities MasterClass - EU edition
21-22 May, 2024
Scope of the ICH Guidelines Q6B for biotechnological products
learn more >>Fundamentals of Pharmacokinetics MasterClass - US edition
28-31 May, 2024
The use of PK during drug development will also be described.
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