title: Regulatory status on the role of in vitro dissolution testing in quality control and biopharmaceutics in Europe.
abstract: An overview is provided regarding the different use of in vitro dissolution and particular related regulatory aspects. The overview attempts to clarify the regulatory requirements in all contexts in which in vitro dissolution data are employed. The different areas comprise the development of new and generic products as well as bioequivalence between different formulations. In vitro dissolution is no longer one issue among others in terms of specifications and batch release only, but is aimed to be a relevant tool for describing biopharmaceutic product characteristics for different purposes in the regulatory environment. Accordingly, the extent of the experiments will depend on the purpose of the in vitro dissolution data.
authors.affiliation: Federal Institute for Drugs and Medical Devices (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175, Bonn, Germany. Jobst.Limberg@bfarm.de
authors.forename: Jobst
authors.initials: J
authors.lastname: Limberg
authors.forename: Henrike
authors.initials: H
authors.lastname: Potthast
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods; D004304:Dosage Forms / Q000592:standards; D017277:Drug Approval; D004335:Drug and Narcotic Control; D005060:Europe; D006801:Humans; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000592:standards; D010599:Pharmacokinetics; D011786:Quality Control; D012995:Solubility; D013810:Therapeutic Equivalency
chemical_list: D004304:Dosage Forms; D004364:Pharmaceutical Preparations
keywords: IVIVC; biopharmaceutic product characteristics; biowaiver; in vitro dissolution; quality control; regulatory status