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VetCAST method for determination of the pharmacokineticpharmacodynamic cut-off values of a long-acting formulation of florfenicol to support clinical breakpoints for florfenicol Antimicrobial Susceptibility Testing in cattle

Toutain, P-L; Sidhu, P K; Lees, P; Rassouli, A; Pelligand, L

Authors

P-L Toutain

P K Sidhu

P Lees

A Rassouli

L Pelligand



Abstract

The PK/PD cut-off (PK/PDCO ) value of florfenicol for calf pathogens was determined for long acting formulations (MSD Nuflor® and a bioequivalent generic product). PK/PDCO is one of the three MICs considered by VetCAST, a sub-committee of the European Committee on Susceptibility Testing, to establish a Clinical Breakpoint for interpreting Antimicrobial Susceptibility Testing. 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 5000 florfenicol disposition curves was generated by Monte Carlo Simulations 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 complex, Pasteurella multocida and Mannheimia haemolytica. It was concluded that the PK/PDCO of florfenicol for both AUC/MIC and T>MIC was 1 mg/L.

Citation

Toutain, P., Sidhu, P. K., Lees, P., Rassouli, A., & Pelligand, L. (2019). VetCAST method for determination of the pharmacokineticpharmacodynamic cut-off values of a long-acting formulation of florfenicol to support clinical breakpoints for florfenicol Antimicrobial Susceptibility Testing in cattle. Frontiers in Microbiology, 10(1310), https://doi.org/10.3389/fmicb.2019.01310

Journal Article Type Article
Acceptance Date May 27, 2019
Publication Date Jun 12, 2019
Deposit Date Jun 5, 2019
Publicly Available Date Jun 5, 2019
Journal Frontiers in Microbiology
Electronic ISSN 1664-302X
Publisher Frontiers Media
Peer Reviewed Peer Reviewed
Volume 10
Issue 1310
DOI https://doi.org/10.3389/fmicb.2019.01310
Public URL https://rvc-repository.worktribe.com/output/1381761

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