Applying Biomarker Information To Support Drug Discovery ... - IIR

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SUMMARY • <strong>Biomarker</strong>: same principles with new name broader coverage and Sig. impact • Values of having high degree surrogacy information • Benefit of being Critical • Importance of setting up adequate assumptions • <strong>To</strong>ol: Modeling & simulation
Acknowledgment PEGSYS Project: PKA signaling pathway PEG-GM-CSF Project: Pascal Bailon Dennis Keith Mary Graves Michael Brenda Alicia Palleroni Ann Goldstein Indra Patel Peter VanBrummelen Stephane Dickenson Joseph Hoffman Simon Pedder …….. Rudy Schreiber Robert England Dennis Deptula Elizabeth Ashford Pascal Bailon Eric Platza Terry Hays Indra Patel
Page 1 and 2: Applying Biomarker Information To S
Page 3 and 4: Definition: Surrogate Endpoint A bi
Page 5 and 6: Develop a New Therapy • Strong Me
Page 7 and 8: PK Profiles of IFN / PEG-IFN in Rat
Page 9 and 10: Comparison of Pharmacokinetic Profi
Page 11 and 12: Good Correlation between Predicted
Page 13 and 14: Good Correlation between Model Pred
Page 15 and 16: Good Correlation between Model Pred
Page 17 and 18: Findings of PKA Signaling Pathway P
Page 19 and 20: Mechanistic Pharmacology Platform i
Page 21 and 22: Graphic Illustration -- Mechanism o
Page 23 and 24: Model Prediction vs Literature Valu
Page 25 and 26: Effect of PEG-G & Filgrastim on ANC
Page 27: Mean BFU-E Colony Formation Profile

Applying Biomarker Information To Support Drug Discovery ... - IIR

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