title: Risk analysis in bioequivalence and biowaiver decisions.
abstract: This article evaluates the current biowaiver guidance documents published by the FDA, EU and WHO from a risk based perspective. The authors introduce the use of a Failure Mode and Effect Analysis (FMEA) risk calculation tool to show that current regulatory documents implicitly limit the risk for bioinequivalence after granting a biowaiver by reduction of the incidence, improving the detection and limiting the severity of any unforeseen bioinequivalent product. In addition, the authors use the risk calculation to expose yet unexplored options for future extension of comparative in vitro tools for biowaivers.
authors.affiliation: National Institute of Public Health and the Environment, Bilthoven, the Netherlands.
authors.forename: Marlies
authors.initials: M
authors.lastname: Kubbinga
authors.forename: Peter
authors.initials: P
authors.lastname: Langguth
authors.forename: Dirk
authors.initials: D
authors.lastname: Barends
mesh_terms: D001682:Biological Availability; D001702:Biopharmaceutics / Q000379:methods; D004304:Dosage Forms / Q000592:standards; D017277:Drug Approval; D004335:Drug and Narcotic Control; D017408:Guidelines as Topic; D006801:Humans; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000592:standards; D010599:Pharmacokinetics; D011786:Quality Control; D012306:Risk; D012995:Solubility; D013810:Therapeutic Equivalency
chemical_list: D004304:Dosage Forms; D004364:Pharmaceutical Preparations
keywords: BCS; FMEA; bioequivalence; biowaiver; risk analysis