BioanalysisVol. 10, No. 21 EditorialIncurred sample reanalysis: 'too much of a good thing?'Eric N FluhlerEric N Fluhler*Author for correspondence: Tel.: +1 914 420 7508; E-mail Address: eric.fluhler@bioanalyticalcompliance.com Bioanalytical Compliance Associates, LLC, 7 Cranberry Road, Washingtonville, NY 10992, USAPublished Online:10 Oct 2018https://doi.org/10.4155/bio-2018-0195AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: bioanalysisISRquality controlregulatedvalidationReferences1 DiMasi JA, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: new estimates of R&D costs. J. Health Econ. 47, 20–33 (2016).Crossref, Medline, Google Scholar2 Fast DM, Kelley M, Viswanathan CT et al. Workshop report and follow-up – AAPS workshop on current topics in GLP bioanalysis: assay reproducibility for incurred samples – implications of Crystal City recommendations. AAPS J. 11(2), 238–241 (2009).Crossref, Medline, Google Scholar3 Fluhler E, Vazvaei F, Singhal P et al. Repeat analysis and incurred sample reanalysis: recommendation for best practices and harmonization from the Global Bioanalysis Consortium Harmonization Team. AAPS J. 16(6), 1167–1174 (2014).Crossref, Medline, CAS, Google Scholar4 New ICH M10 guideline in development on bioanalytical method validation. http://www.ich.org/ichnews/newsroom/read/article/new-ich-m10-guideline-in-development-on-bioanalytical-method-validation.html.Google Scholar5 Rocci ML, Devanarayan V, Haughey DB et al. Confirmatory reanalysis of incurred bioanalytical samples. AAPS J. 9, E336–E343 (2007).Crossref, Medline, CAS, Google ScholarFiguresReferencesRelatedDetailsCited ByComparison of Titer and Signal to Noise (S/N) for Determination of Anti-drug Antibody Magnitude Using Clinical Data from an Industry Consortium12 July 2022 | The AAPS Journal, Vol. 24, No. 4A 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. 5Incurred 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 117 times History Received 20 July 2018 Accepted 27 September 2018 Published online 10 October 2018 Published in print November 2018 Information© 2018 Newlands PressKeywordsbioanalysisISRquality controlregulatedvalidationFinancial & 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

This Land O'Lakes Conference is presented each year by the Division of Pharmacy Professional Development within the School of Pharmacy at the University of Wisconsin-Madison (USA). The purpose of this 3-day conference is to provide an educational forum to discuss issues and applications associated with the analysis of xenobiotics, metabolites, biologics and biomarkers in biological matrices. The conference is designed to include and encourage an open exchange of scientific and methodological applications for bioanalysis. To increase the interactive nature of the conference, the program is a mixture of lectures, interactive discussions and a poster session. This report summarized the presentations at the 16th Annual Conference. 6th Annual Land O'Lakes Bioanalytical Conference, Fluno Center Madison, WI, USA, 13-16 July 2015.

This Land O'Lakes Conference is presented each year by the Division of Pharmacy Professional Development within the School of Pharmacy at the University of Wisconsin-Madison (USA). The purpose of this 3-day conference is to provide an educational forum to discuss issues and applications associated with the analysis of xenobiotics, metabolites, biologics and biomarkers in biological matrices. The conference is designed to include and encourage an open exchange of scientific and methodological applications for bioanalysis. To increase the interactive nature of the conference, the program is a mixture of lectures, interactive discussions and a poster session. This report summarized the presentations at the Fifteenth Annual Conference.

The University of Wisconsin bioanalytical conference is presented each year by the Extension Services in Pharmacy, the professional development department within the School of Pharmacy. The purpose of this 3-day conference was to provide an educational forum to discuss issues and applications associated with the analysis of xenobiotics, metabolites, biologics and biomarkers in biological matrices. The conference was designed to include and encourage an open exchange of scientific and methodological applications for bioanalysis. To increase the interactive nature of the conference the program was composed of a mixture of lectures, interactive discussions, poster sessions and roundtables. This paper summarizes the presentations at the Fourteenth Annual Conference, offered in a new venue.

This University of Wisconsin School of Pharmacy bioanalytical conference is presented each year by the Extension Services in Pharmacy, the professional development department within the School. The purpose of this 4-day conference is to provide an educational forum to discuss issues and applications associated with the analysis of xenobiotics, metabolites, biologics and biomarkers in biological matrices. The conference is designed to include and encourage an open exchange of scientific and methodological applications for bioanalysis. To increase the interactive nature of the conference, the program was a mixture of lectures, poster sessions, round table discussions and workshops. This article summarizes the presentations at the 13th Annual Conference.

This University of Wisconsin School of Pharmacy bioanalytical conference is presented each year by the Extension Services in Pharmacy, the professional development department within the school. The purpose of this 4-day conference is to provide an educational forum to discuss issues and applications associated with the analysis of xenobiotics, metabolites, biologics and biomarkers in biological matrices. The conference is designed to include and encourage an open exchange of scientific and methodological applications for bioanalysis. To increase the interactive nature of the conference, the program was a mixture of lectures, poster sessions, round table discussions and workshops. This article summarizes the presentations at the 12th Annual Conference.