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Perspectives on updates, clarifications and controversies in chromatographic assay guidance for bioanalytical method validation from major regulatory agencies and organizations.
King, Kris; Li, Pei; Pietrasiewicz, Alicia; Goldstein, Stanley.
Afiliação
  • King K; Department of Drug Metabolism and Pharmacokinetics, Biogen, 225 Binney St, Cambridge, MA, 02142, USA.
  • Li P; Department of Drug Metabolism and Pharmacokinetics, Biogen, 225 Binney St, Cambridge, MA, 02142, USA.
  • Pietrasiewicz A; Department of Drug Metabolism and Pharmacokinetics, Biogen, 225 Binney St, Cambridge, MA, 02142, USA.
  • Goldstein S; Department of Drug Metabolism and Pharmacokinetics, Biogen, 225 Binney St, Cambridge, MA, 02142, USA.
Biomed Chromatogr ; 35(1): e5030, 2021 Jan.
Article em En | MEDLINE | ID: mdl-33201529
Bioanalysis, a key supporting function for generating data for pre-clinical and clinical studies in drug development, is under the regulation of local agencies as well as global organizations to ensure the data integrity and quality in submission. As major regulatory agencies and organizations, the US Food and Drug Administration, the European Medicines Agency and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use have been updating their industry guidance for bioanalytical method validation, to keep up with the development new modalities, technologies and regulations. This article summarizes the recent updates and any clarifications and controversies triggered by those updates. Perspectives and recommendations are given based on our own experience as well as commonly accepted practice in the bioanalytical community.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Química Farmacêutica / Cromatografia Tipo de estudo: Diagnostic_studies / Guideline / Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Biomed Chromatogr Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Química Farmacêutica / Cromatografia Tipo de estudo: Diagnostic_studies / Guideline / Prognostic_studies Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Biomed Chromatogr Ano de publicação: 2021 Tipo de documento: Article País de afiliação: Estados Unidos