6533b86dfe1ef96bd12c9343
RESEARCH PRODUCT
Risk analysis in bioequivalence and biowaiver decisions
Peter LangguthDirk M. BarendsMarlies Kubbingasubject
PharmacologyRisk analysisTherapeutic equivalencyComputer sciencePharmaceutical ScienceGuidance documentsGeneral MedicineLimitingBioequivalenceRisk analysis (engineering)Drug approvalPharmacology (medical)Product (category theory)Risk assessmentdescription
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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2013-02-10 | Biopharmaceutics & Drug Disposition |