The design of pharmacokinetic studies to support drug discovery: the selection of the optimum number of animals for a study.
Using historic data from development and pre-development compounds, the variability in plasma concentration (including C(max)) and AUC that would be observed when only 1 or 2 animals per time point are used instead of the normal three has been studied. The results indicate that for pharmacokinetic studies carried out during the early discovery phase the number of animals per time point can be reduced to 2 without significantly affecting the quality of the data. Such an approach is not only more efficient, but it conserves valuable compound and reduces by one third the number of animals employed on the study.
Law
Brian
B
AstraZeneca, Department of Drug Metabolism and Pharmacokinetics, Mereside, Alderley Park, Macclesfield, Cheshire, UK.
Temesi
Dave
D
D000818:Animals; D019540:Area Under Curve; D004305:Dose-Response Relationship, Drug; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000097:blood*; D012107:Research Design / Q000592:standards / Q000706:statistics & numerical data*
D004364:Pharmaceutical Preparations