A Modeling and Simulation Framework to Support Early Clinical Drug Development Decisions in Oncology

Author:

Bruno Rene,Lu Jian-Feng,Sun Yu-Nien,Claret Laurent

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference16 articles.

1. Can the pharmaceutical industry reduce attrition rates?;Kola;Nat Rev Drug Discov,2004

2. Innovation/stagnation: challenge and opportunity on the critical path to new medical products March 2004 http:www.fda.govScienceResearchSpecialTopicsCriticalPathInitiativeCriticalPathOpportunitiesReportsucm077262.htm

3. End-of-phase 2a meetings. FDA guidance for Industry September 2009 http:www.fda.govdownloadsDrugsGuidanceComplianceRegulatoryInformationGuidancesucm079690.pdf

4. Claret L Girard P Zuideveld KP et al A longitudinal model for tumor size measurements in clinical oncology studies PAGE 15 2006 http:www.page-meeting.orgabstract1004

5. Model-based prediction of phase III overall survival in colorectal cancer based on phase II tumor dynamics;Claret;J Clin Oncol,2009

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