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Home » Endpoints, Trial Design for Skin Infection Drugs Are Focus of US FDA Draft Guidance
Endpoints, Trial Design for Skin Infection Drugs Are Focus of US FDA Draft Guidance
September 16, 2010
Antibacterial drug candidates to treat acute bacterial skin and skin structure infections (ABSSIs) should use either a noninferiority or superiority trial design, while superiority trial designs are recommended for milder skin infection treatment candidates, according to a U.S. Food and Drug Administration (FDA) draft guidance.
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