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Conference Report from the European Bioanalysis Forum Workshop: toward harmonized implementation of the ICH M10 guideline.
Timmerman, Philip; Barfield, Matthew; Cowan, Kyra; Ferrari, Luca; Golob, Michaela; Goodman, Joanne; Kall, Morten; Laurén, Anna; Love, Iain; McDougall, Stuart; Nelson, Robert; Pynaert, Gwenda; Staack, Roland F; Verhaeghe, Tom; White, Steve.
Afiliação
  • Timmerman P; European Bioanalysis Forum, Havenlaan 86c b204, Brussels, 1000, Belgium.
  • Barfield M; Roche Innovation Center Welwyn, Roche Pharma Research & Early Development, Welwyn Garden City, Hertfordshire, AL7 1TW, United Kingdom.
  • Cowan K; New Biological Entities Drug Metabolism & Pharmacokinetics, Merck KGaA, Darmstadt, 64293, Germany.
  • Ferrari L; Roche Pharma Research & Early Development (pRED), F.Hoffmann-La Roche Ltd, Basel, 4070, Switzerland.
  • Golob M; Bioanalysis, Nuvisan GmbH, Neu-Ulm, 89231, Germany.
  • Goodman J; Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, CB21 6GH, United Kingdom.
  • Kall M; LCMS Bioanalysis, Non-Clinical Safety Research, H. Lundbeck A/S, Ottiliavej 9, Valby, DK 2500, Denmark.
  • Laurén A; Non-clinical & Clinical Assay Sciences, Global Discovery & Development Sciences, Global Drug Discovery, Novo Nordisk A/S, Maaløv, DK-2760, Denmark.
  • Love I; Charles River Laboratories Edinburgh Limited, Tranent, East Lothian, EH33 2NE, United Kingdom.
  • McDougall S; Bioanalytical Services, Quotient Sciences, Taylor Drive, Alnwick, Northumberland, NE66 2DH, United Kingdom.
  • Nelson R; Scientific Affairs, Labcorp Drug Development, Meyrin, Geneva, 1217, Switzerland.
  • Pynaert G; Bioanalytics, argenx BV, Zwijnaarde, 9052, Belgium.
  • Staack RF; Roche Pharma Research & Early Development, Pharmaceutical Sciences, Roche Innovation Center Munich, Roche Diagnostics GmbH, Penzberg, 82377, Germany.
  • Verhaeghe T; Janssen Research & Development, BDDS, Beerse, 2340, Belgium.
  • White S; GSK, IVIVT-BIB, Gunnells Wood Road, Stevenage, SG1 2NY, United Kingdom.
Bioanalysis ; 14(22): 1407-1411, 2022 Nov.
Article em En | MEDLINE | ID: mdl-36705021
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa / Relatório de Pesquisa Tipo de estudo: Guideline / Prognostic_studies / Qualitative_research Idioma: En Ano de publicação: 2022 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa / Relatório de Pesquisa Tipo de estudo: Guideline / Prognostic_studies / Qualitative_research Idioma: En Ano de publicação: 2022 Tipo de documento: Article