27 Beagles
The study "In Vivo Bioequivalence Pharmacokinetic Values of Canine Generic and New Animal Formulations that are not Systemically Absorbed to Validate an In Vitro Method for Bioequivalence Assessment" requires 27 Beagles. All 27 beagles need to be acquired at the same time. The study requirements dictate that these dogs be intact males, approximately 7 months of age at the time of acquisition, which translates to approximately 9 kg ± 2 kg at the time of arrival. Additional study requirements are that these dogs be obtained from a vendor that only sells purpose bred animals intended for biomedical research. As part of the approved protocol, these dogs will be adopted out at the conclusion of this study in accordance with HHS and GSA guidelines.
Daniel Weingarten, Phone 240-402-7625, Fax 301-827-7101, Email Daniel.Weingarten@fda.hhs.gov
