Dose selection and go/no-go decisions in a second indication by leveraging published clinical trial data for drugs/classes approved in multiple indications
PC6 - Pharmacometrics Phisticuffs 3* – Is Biostatistics a more important partner for drug development than Pharmacometrics, or are they equal partners?
1:30 PM - 2:00 PM MDT
Pharmacometrics Phisticuffs 3* – Is Biostatistics a more important partner for drug development than Pharmacometrics, or are they equal partners?
Model-informed drug development with hyper accelerated time to submission - exemplified with depemokimab regulatory submissions in interleukin-5-driven diseases"
Considerations for physiologically based pharmacokinetic and pharmacodynamic (PBPK-PD) modeling to facilitate drug development in obese and related specific populations
Combining aggregate and individual level data – opportunities and considerations Session title: High-impact Applications of Model-based Meta-analyses (MBMA) in Drug Development
Harnessing Real-World Data to Advance Pharmacometrics in Understudied Populations: Computational Strategies, Study Design, and Machine Learning Approaches
Quantitative Systems Pharmacology for Cardiorenal Drug Development: Integrating Safety and Efficacy Predictions in patients with multiple comorbidities and comedications
Design of a First-in-Human Study for ARV-102, a Brain-Penetrant PROteolysis TArgeting Chimera (PROTAC) LRRK2 Degrader, Using Pharmacokinetic (PK)-Pharmacodynamic (PD) Modeling
Will harmonization in guidance lead to consistency in assessment and regulatory decisions, with a focus on PBPK modeling in new drug approvals (NDAs) and marketing authorization applications (MAAs)?
Panel - FDA’s Model Master Files: Paving the Path for Innovative Technologies and Increased Regulatory Acceptance of Modeling and Simulation Approaches
Machine learning applied to Hepatitis B virtual patients suggests prognostic biomarker signatures for stratifying responders to standard-of-care therapies.
ISoP Education Committee: Unlocking the Value of Physiologically-based Modeling for Small and Large Molecule Therapeutics: Hands-on modeling and simulation with open-source tools, R and PK-sim
ISoP Education Committee: Unlocking the Value of Physiologically-based Modeling for Small and Large Molecule Therapeutics: Hands-on modeling and simulation with open-source tools, R and PK-sim
