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Regulatory Affairs

5 Common FDA Applications for Drugs & Biologics

There are two broad application categories for drugs and biologics regulated by the United States Food and Drug Administration (FDA): requests for authorization for clinical investigations requests for marketing approval…

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IVIVC Flask

What is IVIVC?

An in vitro in vivo correlation (IVIVC) is a predictive mathematical model that describes the relationship between an in vitro property of a dosage form (primarily dissolution or drug release)…

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