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Zdrowie i gospodarka · 5.12.2013

Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended-Release Injectable Suspension; Availability

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Bioequivalence Recommendations for Paliperidone Palmitate." The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for paliperidone palmitate extended-release injectable suspension.

Source: Federal Register — Food and Drug AdministrationOpen original release →