A generic operational strategy to qualify translational safety biomarkers

被引：48

作者：

Matheis, Katja ^{[2
]}

Laurie, David ^{[3
]}

Andriamandroso, Christiane ^{[4
]}

Arber, Nadir ^{[5
]}

Badimon, Lina ^{[6
]}

Benain, Xavier ^{[7
]}

Bendjama, Kaidre ^{[1
]}

Clavier, Isabelle ^{[7
]}

Colman, Peter ^{[8
]}

Firat, Hueseyin ^{[1
]}

Goepfert, Jens ^{[9
]}

Hall, Steve ^{[8
]}

Joos, Thomas ^{[10
]}

Kraus, Sarah ^{[5
]}

Kretschmer, Axel ^{[11
]}

Merz, Michael ^{[3
]}

Padro, Teresa ^{[6
]}

Planatscher, Hannes ^{[9
]}

Rossi, Annamaria ^{[8
]}

Schneiderhan-Marra, Nicole ^{[9
]}

Schuppe-Koistinen, Ina ^{[12
]}

Thomann, Peter ^{[1
]}

Vidal, Jean-Marc ^{[13
]}

Molac, Beatrice ^{[1
]}

机构：

[1] Firalis SAS, F-68330 Huningue, France

[2] Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany

[3] Novartis Pharma AG, Basel, Switzerland

[4] Interface Europe, Brussels, Belgium

[5] Tel Aviv Sourasky Med Ctr, Tel Aviv, Israel

[6] Barcelona Cardiovasc Res Ctr ICCC CISC, Barcelona, Spain

[7] Sanofi Aventis, Paris, France

[8] Pfizer Ltd, Sandwich CT13 9NJ, Kent, England

[9] Nat & Med Sci Inst, Reutlingen, Germany

[10] Expt & Diagnost Immunol GmbH, Reutlingen, Germany

[11] Bayer Schering Pharma AG, Leverkusen, Germany

[12] AstraZeneca R&D, Sodertalje, Sweden

[13] EMA, London, England

来源：

DRUG DISCOVERY TODAY | 2011年 / 16卷 / 13-14期

关键词：

NONPARAMETRIC-ESTIMATION; CHARACTERISTIC CURVES; METHOD VALIDATION; ROC CURVES; SUPPORT; ABSENCE;

D O I：

10.1016/j.drudis.2011.04.011

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：600 / 608

页数：9

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