A Look Back at the Incurred Sample Reanalysis

Abstract

BioanalysisVol. 10, No. 21 EditorialA look back at the incurred sample reanalysisFaye VazvaeiFaye Vazvaei*Author for correspondence: E-mail Address: faye.vazvaei@roche.com Pharmaceutical Research & Early Development Roche Innovation Center, Roche Innovation Center New York, New York, NY 10016, USASearch for more papers by this authorPublished Online:6 Nov 2018https://doi.org/10.4155/bio-2018-0263AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: bioanalysisBMV guidancefailureincurred sample reanalysisISRReferences1 US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Veterinary Medicine (CVM). Guidance for Industry Bioanalytical Method Validation (2001).Google Scholar2 Viswanathan CT, Bansal S, Booth B et al. 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AAPS J. 16(6), 1167–1174 (2014).Crossref, Medline, CAS, Google Scholar10 FDA: early stage drug development costs trigger higher drug costs. http://www.pharmtech.com/fda-early-stage-drug-development-costs-trigger-higher-drug-costs.Google ScholarFiguresReferencesRelatedDetailsCited ByIs Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?5 May 2022 | The AAPS Journal, Vol. 24, No. 3Sensitive and rapid simultaneous quantitation of leucovorin and its major active metabolite 5‐methyl‐tetrahydrofolate in human plasma using a liquid chromatography coupled with triple quadruple mass spectrometry23 January 2022 | Biomedical Chromatography, Vol. 36, No. 4Enantiomeric separation and estimation of stiripentol by liquid chromatography mass spectrometer in human plasma28 June 2020 | SEPARATION SCIENCE PLUS, Vol. 3, No. 8A comprehensive quality control system suitable for academic research: application in a pediatric studyNina Makowski, Agnes M Ciplea, Mohsin Ali, Ilja Burdman, Anke Bartel & Bjoern B Burckhardt Stephanie LäerJörg BreitkreutzIngrid KlingmannFlorian LaglerJan de HoonMichel DalinghausMilica BajceticSaskia de WildtAnne Keatley ClarkeJohannes BreurChristoph MaleLaslo AblonczyThomas MirVladislav VukomanovicMilan DukicIda JovanovicBjoern BurckhardtWilli CawelloKarl KleineAngelika ModerEmina ObarcaninPeter WagnerJennifer WalshAnne van HeckenLucie SpatenkovaAli MohsinBojana BožićMaja BijelićIlja BurdmanAgnes CipleaMuhammed FaisalSamieh FarahaniMartin FeickertTanja GangnusMilica LazicNina MakowskiFabian SüssenbachMarijke van der MeulenSaša PopovićMiro ParezanovićNori SmeetsVanessa SwobodaDragana BojaninStefan ĐorđevićJasminka DragićAnn-Kathrin HolleBosiljka JovičićJovan KošutićGordana KozomaraHaidara MajidJadranka MitrovićSanja NinićMiro ParezanovicVojislav ParezanovicAndrija PavlovićSergej PrijićBranislava RebićIgor StefanovićDaniel TordasIrena VulićevićAnke BartelAndjelka čekoMarissa HerbortsAnnelies HenninkBosiljka KosanovićSanja KosticLjiljana IsailovićJasmina MaksimovicBadies ManaiNada MartinovićGyöngyi MátéMiloš PerišićJelena ReljićRegina PirkerMarta SalamomovicClaudia SchlesnerJutta TinsEva Wissmann4 March 2020 | Bioanalysis, Vol. 12, No. 5A review of the bioanalytical methods for the quantitative determination of capecitabine and its metabolites in biological matrices8 January 2020 | Biomedical Chromatography, Vol. 34, No. 1Incurred sample reproducibilityFaye Vazvaei & Philip Timmerman13 November 2018 | Bioanalysis, Vol. 10, No. 21 Vol. 10, No. 21 Follow us on social media for the latest updates Metrics Downloaded 127 times History Received 16 September 2018 Accepted 5 October 2018 Published online 6 November 2018 Published in print November 2018 Information© 2018 Newlands PressKeywordsbioanalysisBMV guidancefailureincurred sample reanalysisISRFinancial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.No writing assistance was utilized in the production of this manuscript.PDF download