Stability considerations for drug-device combination products-21 CFR part 4 update

Abstract Combination products are therapeutic and diagnostic products that include two or more of the following: drug, biologic, and device. These products are needed for enhanced clinical outcomes and have more than one Mode of Action (MOA). Therefore, they require a more complex regulatory pathway...

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Main Authors: Christopher Latoz (Author), Laure Larkin (Author), Kim Huynh-Ba (Author)
Format: Book
Published: SpringerOpen, 2023-05-01T00:00:00Z.
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3rd Floor Main Library

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