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Invited Paper Session

Improving Dose Selection in Drug Development: Efficient Modeling Approaches Based on Early Data

Sun, Aug 3, 4:00 PM - 5:50 PM Room CC-208B Music City Center

Jose PinheiroOrganizerYongming QuOrganizerYongming QuChair

Biopharmaceutical Section co: Statistics and Pharmacometrics Interest Groupco: ENAR Applied

3 Presentations

Stronger Together: Harnessing PKPD and statistical insights for drug development decisions at Eli Lilly and Company

4:05 PM - 4:30 PM

Parag Garhyan (Global PK/PD/Pharmacometrics, Eli Lilly and Company)

Pharmacokinetics and pharmacodynamics Dose response Clinical Pharmacology Pharmacometrics Population modeling Exposure response

Experience with extrapolating efficacy and safety data across indications to improve/accelerate dose selection: Opportunities and challenges

4:30 PM - 4:55 PM

Thomas Dumortier (Novartis AG)

Extrapolation PK/PD Pharmacometrics

Applying Longitudinal Dose-Response Modeling to Early Phase Data from SAD and MAD Studies for Enhanced Decision-Making

4:55 PM - 5:20 PM

Fei Chen (Johnson & Johnson)

Dose-response modeling, longitudinal analysis, additive exponential model SAD studies, MAD studies, early-phase clinical trials Bayesian hierarchical model, pharmacokinetics, pharmacodynamics

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