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Zdrowie i gospodarka · 15/09/2011

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies To Establish Product Withdrawal Periods; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry ( 207) entitled "Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies To Establish Product Withdrawal Periods," (VICH GL48). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements.

Source: Federal Register — Health and Human ServicesOpen original release →