التفاصيل البيبلوغرافية
| العنوان: |
ISR: background, evolution and implementation, with specific consideration for ligand-binding assays. |
| المؤلفون: |
Findlay JW; Brevard, NC 28712, USA. jwaf115@yahoo.com., Kelley MM |
| المصدر: |
Bioanalysis [Bioanalysis] 2014 Feb; Vol. 6 (3), pp. 393-402. |
| نوع المنشور: |
Journal Article; Review |
| اللغة: |
English |
| بيانات الدورية: |
Publisher: Future Science Country of Publication: England NLM ID: 101512484 Publication Model: Print 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: |
Biological Assay* , Government Regulation* , Safety*, Humans ; Ligands ; United States ; United States Food and Drug Administration |
| مستخلص: |
ISR was highlighted as a topic of major interest to the US FDA in 2006, having been previously required, then discontinued, by Canadian regulatory authorities. Following an FDA focus on ISR, this topic has also been emphasized by regulatory agencies in Europe, Asia and Latin America. Extensive discussions on proper implementation of programs have taken place in multiple settings, including pharmaceutical companies, regulatory agencies, professional associations and CROs. These efforts have led to recommendations for ISR conduct that are now included in a final guideline on bioanalytical method validation from the European Medicines Agency, a draft validation guidance from the Ministry of Health, Labor and Welfare in Japan and a revised draft validation guidance from the FDA. In this Review we look at the background, evolution and implementation of ISR for all assays, while including some specific considerations on this topic for ligand-binding assays. |
| المشرفين على المادة: |
0 (Ligands) |
| تواريخ الأحداث: |
Date Created: 20140130 Date Completed: 20140918 Latest Revision: 20140129 |
| رمز التحديث: |
20221213 |
| DOI: |
10.4155/bio.13.339 |
| PMID: |
24471958 |
| قاعدة البيانات: |
MEDLINE |
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