دورية أكاديمية
EBF recommendation on practical management of critical reagents for PK ligand-binding assays.
| العنوان: | EBF recommendation on practical management of critical reagents for PK ligand-binding assays. |
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| المؤلفون: | Pihl S; Susanne Pihl, Ascendis Pharma A/S, Copenhagen, Denmark., van der Strate BW; PRA Health Sciences, Assen, The Netherlands., Golob M; Nuvisan GmbH, Grafing, Germany., Vermet L; Sanofi Research & Development, Montpellier, France., Jaitner B; Novartis Pharma AG, Basel, Switzerland., Goodman J; MedImmune, Cambridge, UK., Fjording MS; Novo Nordisk A/S, Måløv, Denmark., Timmerman P; European Bioanalysis Forum, Havenlaan 86c b204, 1000 Brussels, Belgium. |
| المصدر: | Bioanalysis [Bioanalysis] 2018 Oct 01; Vol. 10 (19), pp. 1557-1565. Date of Electronic Publication: 2018 Sep 18. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Future Science Country of Publication: England NLM ID: 101512484 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1757-6199 (Electronic) Linking ISSN: 17576180 NLM ISO Abbreviation: Bioanalysis Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: London : Future Science, 2009- |
| مواضيع طبية MeSH: | Indicators and Reagents/*pharmacokinetics, Documentation ; Europe ; Guidelines as Topic ; Indicators and Reagents/metabolism ; Ligands ; Social Control, Formal |
| مستخلص: | Critical reagents play a crucial role in ligand-binding assays; the robustness and reliability of an assay is defined by the quality and long-term availability of these reagents. However, neither regulatory guidelines nor relevant scientific papers provide clear directions for set-up, life cycle management and, more importantly, the acceptance criteria required for the testing of the critical reagents for pharmacokinetic, biomarker and immunogenicity assays. The ambiguity from current guidelines can be a challenge for the bioanalytical community. Members of the European Bioanalysis Forum community undertook a more pragmatic approach on how to assess the impact of critical reagents. In this paper, a review and corresponding gap analysis of the current guidelines and relevant papers will be provided as well as decision trees proposed for lot-to-lot changes of critical reagents for pharmacokinetic assays. |
| فهرسة مساهمة: | Keywords: PK assay; antibodies; critical reagents; ligand-binding assays; major change; minor change |
| المشرفين على المادة: | 0 (Indicators and Reagents) 0 (Ligands) |
| تواريخ الأحداث: | Date Created: 20180919 Date Completed: 20190115 Latest Revision: 20190115 |
| رمز التحديث: | 20221213 |
| DOI: | 10.4155/bio-2018-0230 |
| PMID: | 30226086 |
| قاعدة البيانات: | MEDLINE |
PDF full text from Publisher | تدمد: | 1757-6199 |
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| DOI: | 10.4155/bio-2018-0230 |