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The PK/PD cut-off (PK/PD CO ) value of florfenicol for calf pathogens was determined for long acting formulations (MSD Nuflor® and a bioequivalent generic product). PK/PD CO  is one of the three MICs considered by VetCAST, a sub-committee of the European Committee on Susceptibility Testing (EUCAST), to establish a Clinical Breakpoint for interpreting Antimicrobial Susceptibility Testing (AST). A population model was built by pooling three pharmacokinetic data sets, obtained from 50 richly sampled calves, receiving one of two formulations (the pioneer product and a generic formulation). A virtual population of 5,000 florfenicol disposition curves was generated by Monte Carlo Simulations (MCS) over the 96 h of the assumed duration of action of the formulations. From this population, the maximum predicted MIC, for which 90% of calves can achieve some  a priori  selected critical value for two PK/PD indices, AUC/MIC and T>MIC, was established. Numerical values were established for two bacterial species of the bovine respiratory disease (BRD) complex,  Pasteurella multocida  and  Mannheimia haemolytica . It was concluded that the PK/PD CO  of florfenicol for both AUC/MIC and T>MIC was 1 mg/L.

frontiers in microbiology

VetCAST Method for Determination of the Pharmacokinetic-Pharmacodynamic Cut-Off Values of a Long-Acting Formulation of Florfenicol to Support Clinical Breakpoints for Florfenicol Antimicrobial Susceptibility Testing in Cattle