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

• 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
• ISSN: 0724-8741; 1573-904X
• DOI: 10.1007/s11095-014-1348-9

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.