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Scientific Writing

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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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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IND Requirements and Exemptions

Does my product require an Investigational New Drug (IND) application? It’s a simple question, but the answer can have extensive consequences for your development program. In this post, we will…

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Communicating Effectively with the FDA

One of the most important aspects of any drug development program is the stream of interactions with regulatory authorities like the US Food and Drug Administration (FDA). These interactions can…

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