Bioavailability and bioequivalence trials: statistics & pharmacokinetic principles.
This document has been prepared as a set of workshop material, which will be presented in the International Congress on Medical and Care Compunetics in June 2004 in Den Hague, The Netherlands. The workshop is divided into two parts and deals with the fundamentals of the bioavailability and bioequivalence studies. First part of the workshop deals with the pharmacokinetic principles, and the second part discusses the statistical approaches and the data analysis using the Statistical Analysis Software (SAS).
Rajaram
Lakshminarayan
L
Department of Epidemiology and Biostatistics, University of South Florida, Tampa, Florida, USA.
Roy
Sandip K
SK
Skerjanec
Andrej
A
D000042:Absorption / Q000502:physiology; D001682:Biological Availability; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards* / Q000706:statistics & numerical data*; D003692:Delayed-Action Preparations; D004333:Drug Administration Routes; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods; D004353:Drug Evaluation, Preclinical / Q000592:standards / Q000706:statistics & numerical data; D006801:Humans; D008657:Metabolic Clearance Rate / Q000502:physiology; D010599:Pharmacokinetics; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
D003692:Delayed-Action Preparations