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
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.