Dose optimisation of established veterinary antibiotics in the context of summary of product characteristic (SPC) harmonisation

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Keywords antimicrobial resistance (AMR), summary of product characteristics (SPC), Dose optimisation, pharmacokinetic/pharmacodynamic (PK/PD) modelling, target animal safety (TAS), withdrawal periods (WP) and the environmental risk assessment (ERA)
Description The Committee for Medicinal Products for Veterinary Use (CVMP) started a pilot project on dose optimisation of established veterinary antibiotics to which AnimalhealthEurope (formerly IFAH Europe), and the European Group for Generic Veterinary Products (EGGVP) were invited to provide anonymised data. The results of this project are for consideration by the CVMP for possible future work on the subject.

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