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

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Significance of Critical Reasoning Effects of rolipram in aged mice • Improvement in spatial memory • Improvement in LTP is • Attenuation of impairment in spatial memory PKA signaling plays key role in memory process
Findings of PKA Signaling Pathway Pre-Clinical <strong>Information</strong> • High potency in multiple animal models (all studies were done in rodents) • good or acceptable PK • good or defendable <strong>To</strong>x. package • No QT issues • Clean or defendable safety pharmacology Human Experiences • Peripheral indications ( +, ?) • biomarker • clinical endpoint • Central Effect indications (-, ?) • biomarker • clinical endpoint • manageable safety / tolerability • good or manageable PK
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: Good Correlation between Model Pred
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 and 28: Mean BFU-E Colony Formation Profile
Page 29: Acknowledgment PEGSYS Project: PKA

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

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