Zdrowie i gospodarka · 29/12/2015

Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on paliperidone palmitate extended-release injectable suspension entitled "Draft Guidance on Paliperidone Palmitate."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