Early Feasibility Assessment: A Method for Accurately Predicting Biotherapeutic Dosing to Inform Early Drug Discovery Decisions
Published in Frontiers in Pharmacology
Mechanistic PKPD Models of Protein Therapeutics for Early Clinical Development
Abstract
Mechanistic PKPD models support FIH trial design, development of targeted immunotherapies, and understanding complex PK properties and covariates.
Computational Exploration of ADC Pharmacokinetics
Abstract
The pharmacokinetics of antibody drug conjugate (ADC) therapeutics typically show a discrepancy between the PK of total antibody (conjugated and unconjugated antibody) and that of conjugated antibody, carrying one or more payload molecules. This discrepancy is often attributed to deconjugation (Kamath, 2014), however recent evidence suggests that the underlying mechanisms may be more complex.
Model Firsts: How QSP can Pick the Right Dose for First-in-Human Trials
Abstract
By combining disparate data into coherent mechanistic models, quantitative systems pharmacology is becoming a key tool for picking the right dose for first-in-human trials and other early make-or-break decisions. Advocates see it as part of an expanding toolbox of models that can yield better safety and efficacy predictions from preclinical data, and want regulators to include it in their guidances.
13
Sep
Antibody-Drug Conjugate (ADC) Design
The pharmacokinetics (PK) of antibody-drug conjugates typically show a discrepancy between the PK of total antibody (conjugated and unconjugated antibody) and that of conjugated antibody, carrying one or more payload molecules. This discrepancy is often attributed to deconjugation, however recent evidence suggests that the underlying mechanisms may be more complex.