کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2080395 | 1545147 | 2011 | 9 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
A generic operational strategy to qualify translational safety biomarkers
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موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
بیوتکنولوژی یا زیستفناوری
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چکیده انگلیسی
The importance of using translational safety biomarkers that can predict, detect and monitor drug-induced toxicity during human trials is becoming increasingly recognized. However, suitable processes to qualify biomarkers in clinical studies have not yet been established. There is a need to define clear scientific guidelines to link biomarkers to clinical processes and clinical endpoints. To help define the operational approach for the qualification of safety biomarkers the IMI SAFE-T consortium has established a generic qualification strategy for new translational safety biomarkers that will allow early identification, assessment and management of drug-induced injuries throughout R&D.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Drug Discovery Today - Volume 16, Issues 13–14, July 2011, Pages 600–608
Journal: Drug Discovery Today - Volume 16, Issues 13–14, July 2011, Pages 600–608
نویسندگان
Katja Matheis, David Laurie, Christiane Andriamandroso, Nadir Arber, Lina Badimon, Xavier Benain, Kaïdre Bendjama, Isabelle Clavier, Peter Colman, Hüseyin Firat, Jens Goepfert, Steve Hall, Thomas Joos, Sarah Kraus, Axel Kretschmer, Michael Merz,