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Zdrowie i gospodarka · 16/12/2016

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Bioequivalence: Blood Level Bioequivalence Study; Guidance for Industry; Availability

The US Food and Drug Administration (FDA) has released a guidance document (GFI #224) titled 'Bioequivalence: Blood Level Bioequivalence Study' (VICH GL52) to harmonize data recommendations for veterinary pharmaceutical products, developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

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