Zdrowie i gospodarka · 24/05/1996

Bioequivalence Guidance, 1996; Availability

The Food and Drug Administration (FDA) is announcing the availability of the revised guidance document entitled ``Bioequivalence Guidance, 1996'' prepared by the Center for Veterinary Medicine (CVM). The availability of a draft guideline entitled ``Bioequivalence Guideline (Draft) 1994'' was announced in the Federal Register of March 1, 1995 (60 FR 11097) (hereinafter referred to as the 1994 draft guideline). The 1994 draft guideline was a revision of the 1990 version and covered the following areas: General considerations, blood level studies, pharmacologic endpoints, clinical endpoints, and human food safety. The guidance is intended to assist sponsors of new animal drug applications (NADA's) in the design and analysis of in vivo bioequivalence studies. This notice addresses comments submitted on the 1994 draft guideline.