title: Biorelevant in vitro performance testing of orally administered dosage forms-workshop report.
abstract: 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.
authors.affiliation: National & Kapodistrian University of Athens, Panepistimiopolis, Greece.
authors.forename: Christos
authors.initials: C
authors.lastname: Reppas
authors.forename: Horst-Dieter
authors.initials: HD
authors.lastname: Friedel
authors.forename: Amy R
authors.initials: AR
authors.lastname: Barker
authors.forename: Lucinda F
authors.initials: LF
authors.lastname: Buhse
authors.forename: Todd L
authors.initials: TL
authors.lastname: Cecil
authors.forename: Susanne
authors.initials: S
authors.lastname: Keitel
authors.forename: Johannes
authors.initials: J
authors.lastname: Kraemer
authors.forename: J Michael
authors.initials: JM
authors.lastname: Morris
authors.forename: Vinod P
authors.initials: VP
authors.lastname: Shah
authors.forename: Mary P
authors.initials: MP
authors.lastname: Stickelmeyer
authors.forename: Chikako
authors.initials: C
authors.lastname: Yomota
authors.forename: Cynthia K
authors.initials: CK
authors.lastname: Brown
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical / Q000193:education* / Q000379:methods* / Q000592:standards; D003692:Delayed-Action Preparations / Q000737:chemistry / Q000378:metabolism; D004304:Dosage Forms; D004353:Drug Evaluation, Preclinical / Q000379:methods* / Q000592:standards; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D010599:Pharmacokinetics; D011786:Quality Control; D012995:Solubility
chemical_list: D003692:Delayed-Action Preparations; D004304:Dosage Forms; D004364:Pharmaceutical Preparations