Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing." This draft guidance provides recommendations for sponsors of abbreviated new drug applications (ANDAs) on the design of bioequivalence studies for generic clozapine products. This draft guidance is being issued because an earlier guidance on this topic published in November 1996 needed to be revised to reflect current agency recommendations. Because of significant potential adverse effects, the agency no longer recommends in vivo bioequivalence testing in healthy subjects.