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Biomarker context-of-use: how organizational design can impact the implementation of the appropriate biomarker assay strategy.
Cowan KJ, Golob M, Goodman J, Laurén A, Andersen L, Decker P, Dejager L, Fjording MS, Groenen P, Jasnowski R, Justies N, Kimberg M, Kunz U, Lawrence J, Richter M, Sordé L, Trigt RV, Vermet L, Vitaliti A, Wright M, Timmerman P. Cowan KJ, et al. Among authors: lauren a. Bioanalysis. 2022 Jul;14(13):911-917. doi: 10.4155/bio-2022-0143. Epub 2022 Jul 29. Bioanalysis. 2022. PMID: 35904153
Recommendations and discussion points on immunogenicity, biomarkers, automation/technology and protein-MS from the 2021 European Bioanalysis Forum Focus Workshops.
Timmerman P, Barfield M, Cowan K, Golob M, Goodman J, Kunz U, Laurén A, Love I, Nelson R, Staack RF, Stanta J, van de Merbel N, Wilson A. Timmerman P, et al. Among authors: lauren a. Bioanalysis. 2021 Oct;13(19):1459-1465. doi: 10.4155/bio-2021-0200. Epub 2021 Oct 4. Bioanalysis. 2021. PMID: 34605275
Quantitative polymerase chain reaction in the bioanalytical laboratory and technical and scientific considerations for nonclinical and clinical assay characterization, validation and sample analysis.
Laurén A, Braun M, Cazzin C, Colleti K, Cox C, Dietz L, Emrich T, Geddes K, Herr K, Iles T, Rogue A, Verlinden Y, Timmerman P. Laurén A, et al. Bioanalysis. 2022 Aug;14(16):1085-1093. doi: 10.4155/bio-2022-0170. Epub 2022 Sep 20. Bioanalysis. 2022. PMID: 36125042
Recommendations and feedback from the European Bioanalysis Forum Workshop: 1 year into ICH M10 - keeping our finger on the pulse.
Timmerman P, Barfield M, Portabella EB, Calogero S, Cowan K, Faber J, Ferrari L, Golob M, Goodman J, Goodwin L, Gnoth MJ, Hughes R, Ivanova T, Jordan G, Laurén A, Maux D, McDougall S, Milushewa P, Nelson R, Pynaert G, Sklodowski K, Sleigh R, Struwe P, Verhaeghe T, Wheller R, White S, Zeiser K. Timmerman P, et al. Among authors: lauren a. Bioanalysis. 2024 Mar;16(5):259-270. doi: 10.4155/bio-2024-0013. Epub 2024 Feb 5. Bioanalysis. 2024. PMID: 38315622
36 results