Draft Guidance for Industry: Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format (English, HTML)

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HTML

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Publisher-reported update

2021-06-01

The purpose of this guidance is to define the Common Technical Document (CTD) format of drug submissions which rely on comparative bioavailability studies to establish safety and efficacy. This guidance also references some of the technical requirements related to the conduct and analysis of such studies.

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