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Zdrowie i gospodarka · 29/12/2015

FDA Releases Revised Draft Guidance for Paliperidone Palmitate Bioequivalence Studies

The FDA has made a revised draft guidance for industry available, outlining specific recommendations for designing bioequivalence studies to support abbreviated new drug applications for paliperidone palmitate extended-release injectable suspension.

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