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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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Principles, advantages and potential challenges of the adaptive design methodology
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