Thursday 16 October, 2025
Objectives: Pharmacokinetics (PK) of monoclonal antibodies and in particular their clearances have been reported to be related to body size…
Read morePoster: Applications- Biologicals/vaccines
Pharmacokinetics and Pharmacodynamics of Anti-CD3 Monoclonal Antibody, Otelixizumab, in Subjects with Diabetes and Psoriasis
Thursday 16 October, 2025
Objectives: Otelixizumab, a targeted T cell immunomodulator, is a monoclonal antibody directed against the CD3e part of the T-cell receptor…
Read moreHarnessing clinical knowledge on ligand-targeting drug to develop a new compound targeting the associated receptor : an example of model-based biologics design in pre-clinical development
Thursday 16 October, 2025
Objectives: The modeling work aims at supporting the design of a new biologics compound (B) against a new cellular-receptor target…
Read moreA Mechanism Based Population Pharmacokinetic-Pharmacodynamic Model for Epoetin Alfa and Darbepoetin Alfa in Chronic Kidney Disease Patients
Thursday 16 October, 2025
Objectives: The purpose of this study was to develop a mechanistic longitudinal pharmacokinetic / pharmacodynamic (PK/PD) model for the characterization…
Read moreDevelopment of anti-infliximab antibodies increases infliximab clearance in inflammatory bowel diseases
Thursday 16 October, 2025
Objectives: Infliximab, an anti-TNF-α monoclonal antibody, has profoundly modified the treatment of several inflammatory diseases. The objective of this study…
Read moreMethotrexate influences neither pharmacokinetics nor concentration-effect relationship of infliximab in axial ankylosing spondylitis
Thursday 16 October, 2025
Objectives: The pharmacokinetics of infliximab (IFX), an anti-TNF-α monoclonal antibody, is modified during methotrexate (MTX) coadministration in rheumatoid arthritis[1]. The…
Read moreBayesian framework applied to dose escalation studies for biologics
Thursday 16 October, 2025
Introduction: In phase I dose escalating studies aiming at investigating pharmacokinetics and safety of novel drugs, a range of doses…
Read moreA Mechanistic Approach to Predicting Human Pharmacokinetics of Monoclonal Antibodies from Preclinical Data: A Case Example
Thursday 16 October, 2025
Objectives: The objective of this study was to develop a mechanistic approach to predicting human pharmacokinetics (PK) from in-vitro mechanistic…
Read moreSetting a Safe Starting Dose for a First-in-Man trial of a Monoclonal Antibody Based on Population PK-PD Predictions
Thursday 16 October, 2025
Objectives: The disastrous outcome of a recent phase 1 trial with a monoclonal antibody (mAb) (1) has highlighted the need…
Read moreTarget-Mediated Drug Disposition Model to Describe Non-linear Kinetics of a Monoclonal Antibody
Thursday 16 October, 2025
Introduction: CDP791 is a Monoclonal antibody (Mab) showing non-linear pharmacokinetics. It is a VEGFR-2 (Vascular Endothelial Growth Factor Receptor-2) antagonist…
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