Feasibility of interspecies extrapolation in determining the bioequivalence of animal products intended for intramuscular administration

Citation
Mn. Martinez et al., Feasibility of interspecies extrapolation in determining the bioequivalence of animal products intended for intramuscular administration, J VET PHARM, 24(2), 2001, pp. 125-135
Citations number
34
Categorie Soggetti
Veterinary Medicine/Animal Health
Journal title
JOURNAL OF VETERINARY PHARMACOLOGY AND THERAPEUTICS
ISSN journal
01407783 → ACNP
Volume
24
Issue
2
Year of publication
2001
Pages
125 - 135
Database
ISI
SICI code
0140-7783(200104)24:2<125:FOIEID>2.0.ZU;2-H
Abstract
To examine the validity of extrapolating parenteral product bioequivalence determinations across target animal species, the relative bioavailability o f two injectable formulations of ampicillin trihydrate (Polynex(R), a water -based suspension, and Ampi-kel 10(R), an oil-based suspension) was examine d in calves, sheep and swine. Employing products recognized to be bioinequi valent 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 n oted in the width and bounds of the confidence intervals about the differen ces in treatment means. Potential physiological and physico-chemical reason s for these findings are discussed.