A generic operational strategy to qualify translational safety biomarkers


Por: Matheis, K, Laurie, D, Andriamandroso, C, Arber, N, Badimon, L, Benain, X, Bendjama, K, Clavier, I, Colman, P, Firat, H, Goepfert, J, Hall, S, Joos, T, Kraus, S, Kretschmer, A, Merz, M, Padro, T, Planatscher, H, Rossi, A, Schneiderhan-Marra, N, Schuppe-Koistinen, I, Thomann, P, Vidal, JM, Molac, B

Publicada: 1 jul 2011
Resumen:
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.

Filiaciones:
Matheis, K:
 Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany

Laurie, D:
 Novartis Pharma AG, Basel, Switzerland

Andriamandroso, C:
 Interface Europe, Brussels, Belgium

Arber, N:
 Tel Aviv Sourasky Med Ctr, Tel Aviv, Israel

Badimon, L:
 Barcelona Cardiovasc Res Ctr ICCC CISC, Barcelona, Spain

Benain, X:
 Sanofi Aventis, Paris, France

Bendjama, K:
 Firalis SAS, F-68330 Huningue, France

Clavier, I:
 Sanofi Aventis, Paris, France

Colman, P:
 Pfizer Ltd, Sandwich CT13 9NJ, Kent, England

Firat, H:
 Firalis SAS, F-68330 Huningue, France

Goepfert, J:
 Nat & Med Sci Inst, Reutlingen, Germany

Hall, S:
 Pfizer Ltd, Sandwich CT13 9NJ, Kent, England

Joos, T:
 Expt & Diagnost Immunol GmbH, Reutlingen, Germany

Kraus, S:
 Tel Aviv Sourasky Med Ctr, Tel Aviv, Israel

Kretschmer, A:
 Bayer Schering Pharma AG, Leverkusen, Germany

Merz, M:
 Novartis Pharma AG, Basel, Switzerland

Padro, T:
 Barcelona Cardiovasc Res Ctr ICCC CISC, Barcelona, Spain

Planatscher, H:
 Nat & Med Sci Inst, Reutlingen, Germany

Rossi, A:
 Pfizer Ltd, Sandwich CT13 9NJ, Kent, England

Schneiderhan-Marra, N:
 Nat & Med Sci Inst, Reutlingen, Germany

Schuppe-Koistinen, I:
 AstraZeneca R&D, Sodertalje, Sweden

Thomann, P:
 Firalis SAS, F-68330 Huningue, France

Vidal, JM:
 EMA, London, England

Molac, B:
 Firalis SAS, F-68330 Huningue, France
ISSN: 13596446





DRUG DISCOVERY TODAY
Editorial
ELSEVIER SCI LTD, THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND, Reino Unido
Tipo de documento: Review
Volumen: 16 Número: 13-14
Páginas: 600-608
WOS Id: 000292719200008
ID de PubMed: 21570476

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