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Zdrowie i gospodarka · 1.03.1995

Revised Bioequivalence Guideline; Draft; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guideline entitled ``Bioequivalence Guideline (Draft) 1994'' prepared by the Center for Veterinary Medicine (CVM). The draft guideline, which is a revision of the 1990 version, covers general considerations, blood level studies, pharmacologic end-points, clinical end-points, and human food safety. The draft guideline is intended to assist sponsors of new animal drug applications in the submission of data to support approval of these applications.

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