Control of the active substance in the finished product for immunological veterinary medicinal products (IVMPs) - Scientific guideline

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This document discusses the different methods currently used for control of the active substance in the finished product and their features, difficulties associated with the validation of these tests, problems arising from the use of in vivo tests and the possibility of an alternative in vitro approach for the batch testing.

Keywords: Potency test, batch potency test, immunological veterinary medicinal product (IVMP), in vitro methods, live vaccines, inactivated vaccines, batch titre, measurement of inactivated antigens

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