A Mechanistic, Model-Based Approach to Safety Assessment in Clinical Development

Author:

Lippert J1,Brosch M2,von Kampen O2,Meyer M1,Siegmund H.-U1,Schafmayer C3,Becker T3,Laffert B4,Görlitz L1,Schreiber S2,Neuvonen PJ56,Niemi M56,Hampe J2,Kuepfer L1

Affiliation:

1. Computational Systems Biology, Bayer Technology Services GmbH; Leverkusen Germany

2. Department of Internal Medicine I; University Hospital Schleswig-Holstein, Campus Kiel, Christian-Albrechts-University; Kiel Germany

3. Department of General and Thoracic Surgery; University Hospital Schleswig-Holstein, Campus Kiel, Christian-Albrechts-University; Kiel Germany

4. Cell Culture Service; Hamburg Germany

5. Department of Clinical Pharmacology; University of Helsinki; Helsinki Finland

6. HUSLAB, Helsinki University Central Hospital; Helsinki Finland

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Reference48 articles.

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3. Market withdrawal of new molecular entities approved in the United States from 1980 to 2009;Qureshi;Pharmacoepidemiol. Drug Saf.,2011

4. In silico toxicology for the pharmaceutical sciences;Valerio;Toxicol. Appl. Pharmacol.,2009

5. Web tools for predictive toxicology model building;Jeliazkova;Expert Opin. Drug Metab. Toxicol.,2012

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