Improving data integrity in regulated bioanalysis: proposal for a generic data transfer process for LC-MS from the European Bioanalysis Forum.

Arfvidsson, Cecilia; Bedaf, David Van; Globig, Susanne; Knutsson, Magnus; Lewis, Mark; McDougall, Stuart; Michi, Marco; Timmerman, Philip

Arfvidsson, Cecilia; Bedaf, David Van; Globig, Susanne; Knutsson, Magnus; Lewis, Mark; McDougall, Stuart; Michi, Marco; Timmerman, Philip.

Afiliação

Arfvidsson C; Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.
Bedaf DV; Nonclinical Safety, Janssen R&D, Beerse, Belgium.
Globig S; Drug Metabolism & Pharmacokinetics, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.
Knutsson M; Bioanalysis, Ferring, Copenhagen, Denmark.
Lewis M; Bioanalysis Immunogenicity & Biomarkers, GlaxoSmithKline R&D, Ware, UK.
McDougall S; Bioanalytical Services, ARCinova, Alnwick, UK.
Michi M; Pharmacokinetics & Drug Metabolism, Menarini Ricerche S.p.A., Pomezia, Italy.
Timmerman P; European Bioanalysis Forum vzw (EBF), Havenlaan 86c b204, 1000 Brussel, Belgium.

Bioanalysis ; 12(14): 1033-1038, 2020 Jul.

Article em En | MEDLINE | ID: mdl-32706625

Assuntos

Bioensaio/métodos; Cromatografia Líquida/métodos; Espectrometria de Massas em Tandem/métodos; Europa (Continente); Humanos

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Bioensaio / Cromatografia Líquida / Espectrometria de Massas em Tandem Limite: Humans País/Região como assunto: Europa Idioma: En Ano de publicação: 2020 Tipo de documento: Article

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