Biorelevant In Vitro Performance Testing of Orally Administered Dosage Forms—Workshop Report

Biorelevant in vitro performance testing of orally administered dosage forms has become an important tool for the assessment of drug product in vivo behavior. An in vitro performance test which mimics the intraluminal performance of an oral dosage form is termed biorelevant. Biorelevant tests have b...

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Bibliographic Details
Published in:Pharmaceutical research 2014-07, Vol.31 (7), p.1867-1876
Main Authors: Reppas, Christos, Friedel, Horst-Dieter, Barker, Amy R., Buhse, Lucinda F., Cecil, Todd L., Keitel, Susanne, Kraemer, Johannes, Morris, J. Michael, Shah, Vinod P., Stickelmeyer, Mary P., Yomota, Chikako, Brown, Cynthia K.
Format: Article
Language:English
Subjects:
Administration, Oral
Biochemistry
Biomedical and Life Sciences
Biomedical Engineering and Bioengineering
Biomedicine
Chemistry, Pharmaceutical - education
Chemistry, Pharmaceutical - methods
Chemistry, Pharmaceutical - standards
Delayed-Action Preparations - chemistry
Delayed-Action Preparations - metabolism
Dosage Forms
Drug Evaluation, Preclinical - methods
Drug Evaluation, Preclinical - standards
Drug therapy
Health risk assessment
Humans
Medical Law
Meeting Report
Pharmaceutical Preparations - administration & dosage
Pharmaceuticals
Pharmacokinetics
Pharmacology/Toxicology
Pharmacy
Quality Control
Solubility
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Summary:Biorelevant in vitro performance testing of orally administered dosage forms has become an important tool for the assessment of drug product in vivo behavior. An in vitro performance test which mimics the intraluminal performance of an oral dosage form is termed biorelevant. Biorelevant tests have been utilized to decrease the number of in vivo studies required during the drug development process and to mitigate the risk related to in vivo bioequivalence studies. This report reviews the ability of current in vitro performance tests to predict in vivo performance and generate successful in vitro and in vivo correlations for oral dosage forms. It also summarizes efforts to improve the predictability of biorelevant tests. The report is based on the presentations at the 2013 workshop, Biorelevant In Vitro Performance Testing of Orally Administered Dosage Forms, in Washington, DC, sponsored by the FIP Dissolution/Drug Release Focus Group in partnership with the American Association of Pharmaceutical Scientists (AAPS) and a symposium at the AAPS 2012 Annual meeting on the same topic.
ISSN:0724-8741
1573-904X
DOI:10.1007/s11095-014-1348-9