Premium
Feasibility of interspecies extrapolation in determining the bioequivalence of animal products intended for intramuscular administration
Author(s) -
Martinez M. N.,
Pedersoli W. M.,
Ravis W. R.,
Jackson J. D.,
Cullison R.
Publication year - 2001
Publication title -
journal of veterinary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.527
H-Index - 60
eISSN - 1365-2885
pISSN - 0140-7783
DOI - 10.1046/j.1365-2885.2001.00316.x
Subject(s) - bioequivalence , bioavailability , extrapolation , confidence interval , animal species , chromatography , pharmacology , chemistry , zoology , biology , mathematics , statistics
To examine the validity of extrapolating parenteral product bioequivalence determinations across target animal species, the relative bioavailability of two injectable formulations of ampicillin trihydrate (Polyflex R , a water‐based suspension, and Ampi‐kel 10 R , an oil‐based suspension) was examined in calves, sheep and swine. Employing products recognized to be bioinequivalent provided an opportunity to explore potential species‐by‐formulation interactions. As compared with Polyflex R , Ampi‐kel 10 R exhibited lower area under the curve ( AUC ) estimates but higher peak concentrations in all target animal species. Nevertheless, marked interspecies differences were noted in the width and bounds of the confidence intervals about the differences in treatment means. Potential physiological and physico‐chemical reasons for these findings are discussed.