Bioavailability and bioequivalence trials: statistics & pharmacokinetic principles

Lakshminarayan Rajaram; Sandip K Roy; Andrej Skerjanec

Bioavailability and bioequivalence trials: statistics & pharmacokinetic principles

Stud Health Technol Inform. 2004:103:159-79.

Authors

Lakshminarayan Rajaram¹, Sandip K Roy, Andrej Skerjanec

Affiliation

¹ Department of Epidemiology and Biostatistics, University of South Florida, Tampa, Florida, USA.

PMID: 15747918

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).

Publication types

Review

MeSH terms

Absorption / physiology
Biological Availability
Clinical Trials as Topic / legislation & jurisprudence
Clinical Trials as Topic / standards*
Clinical Trials as Topic / statistics & numerical data*
Delayed-Action Preparations
Drug Administration Routes
Drug Approval / legislation & jurisprudence
Drug Approval / methods
Drug Evaluation, Preclinical / standards
Drug Evaluation, Preclinical / statistics & numerical data
Humans
Metabolic Clearance Rate / physiology
Pharmacokinetics*
Therapeutic Equivalency
United States
United States Food and Drug Administration

Substances

Delayed-Action Preparations