Exposure/Response vs. Dose/Response Relationships in Drug Development
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Pharmaceutical Industry Perspectives on Exposure-Response Confounding in Large Molecule Therapeutics: Results From an IQ Consortium Survey. [PDF]
Salama E +13 more
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Clinical Impact of Target-Mediated Drug Disposition of Small Molecules with Focus on Early Phase I Study Designs. [PDF]
Tessaro F +6 more
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M.J. Phillips, R. Thomas, R.J. Davies
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Time-Dependent Bias and Prognostic Confounding in Exposure-Response Analysis of Targeted Therapies: Lessons from Sunitinib in Metastatic Renal Cancer. [PDF]
Liu H, Friberg LE.
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Evolutionary Antifragile Therapy Is a Treatment Strategy to Suppress Drug Resistance by Exploiting Dose-Response Convexity. [PDF]
West J +6 more
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Model-Informed Drug Development (MIDD) for Analgesics: Review of Applications, Regulatory Integration, and Emerging Directions. [PDF]
Dahan A +4 more
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Hierarchical Composite Endpoints for Dose Optimization in Early Phase Oncology Trials. [PDF]
Wu Y, Guo X, Li R, Le Corre C.
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Population Pharmacokinetic, Exposure-Response Efficacy and Safety Analyses of Favezelimab in Patients With Solid Tumors. [PDF]
Gaurav M +4 more
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Successful Translational Prediction of Bedaquiline's Phase 2a Clinical Trial Results against Tuberculosis: The Zebrafish as a New Approach Methodology. [PDF]
van Lieshout B +3 more
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