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Scientific Writing

What Is CDISC and What Are CDISC Data Standards?

CDISC stands for the “Clinical Data Interchange Standards Consortium,” and is a global not-for-profit organization that actively develops data standards with the collective knowledge and experience of volunteers within the…

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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?

Content originally posted April 2016 and updated on October 23, 2019 An in vitro in vivo correlation (IVIVC) is a predictive mathematical model that describes the relationship between an in…

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