BioanalysisVol. 10, No. 21 EditorialIncurred sample reproducibility in pharmacokinetic bioanalysis: pros and cons from a CRO perspectiveBrittany Maria Timmons, Laura Hay, Jim Gorman & Bruce StoufferBrittany Maria Timmons*Author for correspondence: E-mail Address: Brittany.Timmons@ppdi.com PPD, Immunochemistry, Richmond, VA 23230, USASearch for more papers by this author, Laura Hay PPD, Immunochemistry, Richmond, VA 23230, USASearch for more papers by this author, Jim Gorman PPD, Immunochemistry, Richmond, VA 23230, USASearch for more papers by this author & Bruce Stouffer PPD, Immunochemistry, Richmond, VA 23230, USASearch for more papers by this authorPublished Online:6 Nov 2018https://doi.org/10.4155/bio-2018-0245AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleKeywords: bioanalysisCROFDAincurredISRPKReferences1 Fast D, Kelley M, Viswanathan C 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 Scholar2 Timmerman P, Luedtke S, Amsterdam P, Klöppel M, Lausecker B. Incured sample reproducibility: views and recommendations by the European Bioanalysis Forum. Bioanalysis 1(6), 1049–1056 (2009).Link, CAS, Google Scholar3 US FDA. Center for Drug Evaluation and Research (CDER), & Center for Veterinary Medicine (CVM). In: Bioanalytical Method Validation Guidance for Industry. US FDA, Silver Spring, MD, USA (2018).Google Scholar4 European Medicines Agency. Guideline on Bioanalytical Method Validation. European Medicines Agency, London, UK (2011).Google Scholar5 European Bioanalyisis Forum, EBF steering committee; Timmerman P, Lausecker B, Klöppel M, Abbott R. Incurred Sample Reanalysis: EBF's Perspective and Experience (2008). https://amitpatel745.files.wordpress.com/2010/05/isr.pdf.Google ScholarFiguresReferencesRelatedDetailsCited ByIncurred 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 85 times History Received 11 September 2018 Accepted 8 October 2018 Published online 6 November 2018 Published in print November 2018 Information© 2018 Newlands PressKeywordsbioanalysisCROFDAincurredISRPKFinancial & competing interests disclosureThe authors have 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