Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib
This study demonstrates how a model-informed, totality-of-evidence approach was used to select the optimal clinical…
Danielle PillsburyApril 2, 2026
Where Did the 80-125% Bioequivalence Criteria Come From?
Discover what bioequivalence criteria mean, why the 80-125% bioequivalence range is used, and how custom…
CertaraMarch 27, 2026
Integrated PK/PD Modeling and Machine Learning to Support CNS Compound Selection
PK/PD Modeling for CNS drug development using Phoenix NLME and machine learning for better CNS…
CertaraMarch 26, 2026
Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics
This review article examines the development of radiopharmaceutical imaging agents and radioligand therapies for pediatric…
CertaraMarch 26, 2026
Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)
Watch this on-demand webinar to learn how model-informed strategies using PopPK, PBPK, and QSP can…
CertaraMarch 25, 2026
Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Analysis for Clazakizumab in Patients With End-Stage Kidney Disease Undergoing Dialysis
This study evaluated the pharmacokinetics (PK) and pharmacokinetic–pharmacodynamic (PK–PD) relationship of clazakizumab, an anti–interleukin-6 (IL-6)…
Danielle PillsburyMarch 24, 2026
Model-informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis
This article describes how a model-informed drug development (MIDD) approach was used to support the…
CertaraMarch 24, 2026
Regulatory horizons 2026: clinical pharmacology strategy and regulatory expectations
Learn how regulatory expectations in clinical pharmacology are evolving and how to build a strategy…
CertaraMarch 24, 2026
From Numbers to Narrative: Mastering the Art of PK Presentation
Master PK data reporting with a structured guide to presenting pharmacokinetic results clearly and turning…
CertaraMarch 20, 2026
