Michaela Golob - Nuvisan GmbH | 人才画像

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Papers共 32 篇Author StatisticsCo-AuthorSimilar Experts

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Recent Discussions and Proposals on Challenging the 3-Tier Immunogenicity Testing Strategies from the European Bioanalysis Forum

Kyra J Cowan,Karien Bloem, Annelies Coddens, Laura Creed, Hannah Higgins, Jonathan Jimenez Novoa, Christopher Jones, Yvonne Katterle, Marco Klinge, Ben Leatherdale, Birgit Jaitner, Peter van Bommel, Saskia van der Lee,Michaela Golob, Rob Nelson,Philip Timmerman

Bioanalysisno. 9 (2025): 575-578

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Feedback from a Workshop by the European Bioanalysis Forum on Assay Validation Requirements for in Vitro Assays Following the Publication of ICH M12 Guideline - a Plea for Context-of-use over ICH M10 Standards

Philip Timmerman,Steve White,Neil Adcock,Cecilia Arfvidsson,Matthew Barfield,Kyra Cowan,Luca Ferrari,Michaela Golob,Lee Goodwin, Richard Hughes, Tsvetelina Ivanova,Anna Laurén,Stuart McDougall,Robert Nelson,Nico van de Merbel,Tom Verhaeghe,Michael Wright

Bioanalysisno. 6 (2025): 379-382

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A European Bioanalysis Forum Recommendation for Requiring a Context-of-use Statement for Successful Development and Validation of Biomarker Assays

Kyra J. Cowan,Ulrich Kunz,Peter Blattmann, Pratiksha Gulati, Richard Hughes,Lene Andersen,Joanne Goodman, Frazer Lambert, James Lawrence, Daniel Thwaites,Michaela Golob,Robert Nelson,Philip Timmerman

BIOANALYSISno. 16 (2024): 835-842

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Recommendations and Feedback from the European Bioanalysis Forum Workshop: 1 Year into ICH M10-keeping Our Finger on the Pulse

Philip Timmerman,Matthew Barfield, Enric Bertran Portabella,Salvatore Calogero,Kyra Cowan, Joerg Faber,Luca Ferrari,Michaela Golob, Jo Goodman,Lee Goodwin,Mark Jean Gnoth, Richard Hughes, Tsvetelina Ivanova,Gregor Jordan,Anna Lauren, Delphine Maux,Stuart Mcdougall, Petya Milushewa,Robert Nelson,Gwenda Pynaert, Kamil Sklodowski,Rebecca Sleigh,Petra Struwe,Tom Verhaeghe,Robert Wheller,Steve White, Katja Zeiser

Bioanalysisno. 5 (2024): 259-270

Cited1Views0WOSBibtex

Re-thinking the Current Paradigm for Clinical Immunogenicity Assessment: an Update from the Discussion in the European Bioanalysis Forum

Joanne Goodman,Kyra J. Cowan,Michaela Golob,Robert Nelson,Daniel Baltrukonis,Karien Bloem, Brendy Van Butsel, Lysie Champion, John Cook, Minh Dang, Desislava Galeva, Davide Guerrieri,Gregor Jordan,Carsten Krantz, Ching-Hai Lai, Toralf Roch, Adriano Luis Soares de Sonza,Lauren Stevenson, Luis Perez Tosar, Foka Venema, Hanna Widmaier,Philip Timmerman

BIOANALYSISno. 17-18 (2024): 905-913

Cited4Views0WOSBibtex

The European Bioanalysis Forum Recommendation on Establishing Appropriate Drug Tolerance Levels in Antidrug Antibody Assays

Kyra J. Cowan, Lysie Champion, Daniel Dyer, Morten Funch Carlsen, Laura Geary,Jean-Christophe Genin,Michaela Golob,Joanne Goodman,Arno Kromminga, Rob Nelson, Heather Revell, Martin Rieger, Ortwin Van de Vyver, Foka Venema,Philip Timmerman

Bioanalysispp.1-7, (2024)

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Conference Report from the European Bioanalysis Forum Workshop: Toward Harmonized Implementation of the ICH M10 Guideline

Philip Timmerman,Matthew Barfield,Kyra Cowan,Luca Ferrari,Michaela Golob,Joanne Goodman, Morten Kall,Anna Lauren,Iain Love,Stuart McDougall,Robert Nelson,Gwenda Pynaert,Roland F. Staack,Tom Verhaeghe,Steve White

BIOANALYSIS (2023)

Cited4Views0WOSBibtex

Biomarker Context-of-use: How Organizational Design Can Impact the Implementation of the Appropriate Biomarker Assay Strategy

Kyra J. Cowan,Michaela Golob,Joanne Goodman,Anna Lauren,Lene Andersen, Philip De Decker,Lien Dejager,Marianne Scheel Fjording,Peter Groenen,Renaud Jasnowski,Nicole Justies, Matti Kimberg,Ulrich Kunz, James Lawrence,Mario Richter, Laetitia Sorde, Radboud van Trigt,Laurent Vermet,Alessandra Vitaliti, Michael Wright,Philip Timmerman

Bioanalysis（2022）

Cited6Views0WOSBibtex

Recommendations and Discussion Points on Immunogenicity, Biomarkers, Automation/technology and Protein-Ms from the 2021 European Bioanalysis Forum Focus Workshops

Philip Timmerman,Matthew Barfield,Kyra Cowan,Michaela Golob,Joanne Goodman,Ulrich Kunz,Anna Lauren,Iain Love,Robert Nelson,Roland F. Staack, Johannes Stanta,Nico van de Merbel,Amanda Wilson

Bioanalysis（2021）

Cited4Views0WOSBibtex

Update to the European Bioanalysis Forum Recommendation on Biomarkers Assays; Bringing Context of Use into Practice

Joanne Goodman,Kyra J. Cowan,Michaela Golob, Lars Karlsson,Ulrich Kunz,Robert Nelson,Hans Ulrichts,Lauren Stevenson,Linda Terry,Philip Timmerman

Bioanalysis（2020）

Cited17Views0WOSBibtex

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