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
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