Discriminating Bioavailability from Clearance Changes for Oral Drug-drug Metabolic Interactions Leslie Z. Benet, Ph.D., FAAPS – University of California At San Francisco
3:15 PM - 3:30 PM
Biopharmaceutic In-Vitro In-Vivo Extrapolation Informed PBPK Model of Ritonavir Absorption Sumit Arora, PhD – Certara UK (Simcyp Division)
3:30 PM - 3:45 PM
Utilization of MAT Changes to Implicate Transporter-Involvement in Oral DDIs Jasleen Sodhi – University of California San Francisco
3:45 PM - 4:00 PM
PBPK Modelling of Transdermal Selegiline Disposition Discrepancy in Special Populations Santosh Kumar Puttrevu, PhD – Certara UK (Simcyp Division)
4:00 PM - 4:15 PM
Characterization of Hepatic Impairment Effect: Review of FDA Oncology Approvals Ali Ahmed Alhadab, PharmD, MS, PhD – Pfizer Inc.
4:15 PM - 4:30 PM
Dose Recommendation for Hepatic Impairment: Lessons from FDA Oncology Approvals Mohamed Elmeliegy, PhD – Pfizer Inc.
4:30 PM - 4:45 PM
Regulatory Perspective for using Exposure-response Analysis for QT Assessment Nan Zheng, PhD – US Food and Drug Administration
4:45 PM - 5:00 PM
Mechanism-Based Population Pharmacokinetic/Pharmacodynamic (PKPD) Modeling of ISIS 702843, a TMPRSS6 Targeting Antisense Oligonucleotide (ASO) to Guide Early Clinical Development Charvi Nanavati, PhD – Ionis Pharmaceuticals