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A recent report found that generic parenteral vancomycin products may not havein vivo efficacies equivalent to those of the innovator in a neutropenic murine thigh infection model despite having similarin vitro microbiological activities and murine serum pharmacokinetics. We compared thein vitro andin vivo activities of six of the parenteral vancomycin products available in the United States. Thein vitro assessments for the potencies of the vancomycin products included MIC/minimal bactericidal concentration (MBC) determinations, quantifying the impact of human and murine serum on the MIC values, and time-kill studies. Also, the potencies of the vancomycin products were quantified with a biological assay, and the human and mouse serum protein binding rates for the vancomycin products were measured. Thein vivo studies included dose-ranging experiments with the 6 vancomycin products for three isolates ofStaphylococcus aureus in a neutropenic mouse thigh infection model. The pharmacokinetics of the vancomycin products were assessed in infected mice by population pharmacokinetic modeling. No differences were seen across the vancomycin products with regard to anyin vitro evaluation. Inhibitory sigmoid maximal bacterial kill (E max ) modeling of the relationship between vancomycin dosage and the killing of the bacteria in micein vivo yielded similarE max and EC50 (drug exposure driving one-halfE max ) values for bacterial killing. Further, there were no differences in the pharmacokinetic clearances of the 6 vancomycin products from infected mice. There were no important pharmacodynamic differences in thein vitro orin vivo activities among the six vancomycin products evaluated.

Pharmacodynamic Evaluation of the Activities of Six Parenteral Vancomycin Products Available in the United States