P-L Toutain
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 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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