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Preclinical Development
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Rapid Fire Preclinical
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Rapid Fire Clinical Pharmacology
Rapid Fire Clinical Pharmacology
Rapid Fire Clinical Pharmacology
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Monday, Nov 4
3:00 pm
Discriminating Bioavailability from Clearance Changes for Oral Drug-drug Metabolic Interactions
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Leslie Z. Benet, Ph.D., FAAPS – University of California At San Francisco
Monday, Nov 4
3:00 pm
Rapid Fire: Clinical Pharmacology
Location: Presentation Room 1, Exhibit Hall 2, 3 and 4
Bart Hens, PharmD, PhD – KU Leuven; Palak Phansalkar, B. Pharm – Virginia Commonwealth University
Monday, Nov 4
3:15 pm
Biopharmaceutic In-Vitro In-Vivo Extrapolation Informed PBPK Model of Ritonavir Absorption
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Sumit Arora, PhD – Certara UK (Simcyp Division)
Monday, Nov 4
3:30 pm
Utilization of MAT Changes to Implicate Transporter-Involvement in Oral DDIs
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Jasleen Sodhi – University of California San Francisco
Monday, Nov 4
3:45 pm
PBPK Modelling of Transdermal Selegiline Disposition Discrepancy in Special Populations
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Santosh Kumar Puttrevu, PhD – Certara UK (Simcyp Division)
Monday, Nov 4
4:00 pm
Characterization of Hepatic Impairment Effect: Review of FDA Oncology Approvals
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Ali Ahmed Alhadab, PharmD, MS, PhD – Pfizer Inc.
Monday, Nov 4
4:15 pm
Dose Recommendation for Hepatic Impairment: Lessons from FDA Oncology Approvals
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Mohamed Elmeliegy, PhD – Pfizer Inc.
Monday, Nov 4
4:30 pm
Regulatory Perspective for using Exposure-response Analysis for QT Assessment
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Nan Zheng, PhD – US Food and Drug Administration
Monday, Nov 4
4:45 pm
Mechanism-Based Population Pharmacokinetic/Pharmacodynamic (PKPD) Modeling of ISIS 702843, a TMPRSS6 Targeting Antisense Oligonucleotide (ASO) to Guide Early Clinical Development
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Charvi Nanavati, PhD – Ionis Pharmaceuticals
Monday, Nov 4
3:00 pm
What Makes Polysorbate Functional? Impact of polysorbate80 grade and quality
Location: Presentation Room 7, Exhibit Hall 2, 3 and 4
Tim Menzen, PhD – Coriolis Pharma
Tuesday, Nov 5
3:45 pm
Multi-scale PK Modeling of Biotherapeutic Formulations Injected in Human Subcutaneous (SC) Tissue
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Fudan Zheng, MS – Purdue University
Tuesday, Nov 5
3:00 pm
Visualizing Parameter Source Reliability and Sensitivity for QSP Models
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Abhishek Gulati, Ph.D. – Astellas Pharma Global Development
Tuesday, Nov 5
3:00 pm
Rapid Fire: Clinical Pharmacology
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Amitava Mitra, Ph.D. – Sandoz, USA
Tuesday, Nov 5
3:15 pm
Use of Immunogenicity Assay Signal to Noise within PK Models
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Diana Montgomery, PhD – Merck and Co Inc
Tuesday, Nov 5
3:30 pm
A New Approach to the Development of Biosimilars
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Jaap Wieling, Ph.D. – BiOraliX bv
Tuesday, Nov 5
4:00 pm
Assessment of Target Inhibition Using a PK/PD Model following Intravitreal Administration of an Anti-HtrA1 Antigen-Binding Fragment
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Katie Maass, PhD – Genentech
Tuesday, Nov 5
4:15 pm
Mean Residence Time for Monoclonal Antibodies
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Shuaibing Liu, MD – UCSF
Tuesday, Nov 5
4:30 pm
The Impact of Glycosylation Composition on Pharmacokinetics (PK) of Monoclonal Antibodies
Location: Presentation Room 2, Exhibit Hall 2, 3 and 4
Jimena Dancy, PhD – University of Maryland
Wednesday, Nov 6
3:00 pm
Clearance is Driven by Exposure and Always Model Dependent
Location: Presentation Room 2, Exhibit Hall 4
Leslie Z. Benet, Ph.D., FAAPS – University of California At San Francisco
Wednesday, Nov 6
3:00 pm
Rapid Fire: Clinical Pharmacology
Location: Presentation Room 2, Exhibit Hall 4
Islam Younis
Wednesday, Nov 6
3:15 pm
Predict Human Milk/Plasma Concentration Ratio of Drugs Using IVIVE
Location: Presentation Room 2, Exhibit Hall 4
Peng Zou, PhD – US Food and Drug Administration
Wednesday, Nov 6
3:30 pm
Using Bootstrap Cross-validation to Improve Model Selection in Pharmacometrics
Location: Presentation Room 2, Exhibit Hall 4
James S. Cavenaugh, PhD, MS – n/a
Wednesday, Nov 6
3:45 pm
Randomized, Open-Label, Single-Dose, Crossover Pharmacokinetic Study of Multiple-Dose and Single-Dose Vial Epoetin Alfa-Epbx, an Epoetin Alfa Biosimilar, by Subcutaneous Dosing in Healthy Subjects
Location: Presentation Room 2, Exhibit Hall 4
Hsuan-Ming Yao, PhD – Pfizer
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