title: Bioavailability and bioequivalence trials: statistics & pharmacokinetic principles.
abstract: 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).
authors.affiliation: Department of Epidemiology and Biostatistics, University of South Florida, Tampa, Florida, USA.
authors.forename: Lakshminarayan
authors.initials: L
authors.lastname: Rajaram
authors.forename: Sandip K
authors.initials: SK
authors.lastname: Roy
authors.forename: Andrej
authors.initials: A
authors.lastname: Skerjanec
mesh_terms: 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
chemical_list: D003692:Delayed-Action Preparations