Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations Webinar Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations Danielle PillsburyApril 2, 2026
Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib Publication 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
Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics Publication 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
An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors Publication An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors This publication highlights how pharmacometric modeling, supported by Certara, was used to inform dose selection…CertaraMarch 25, 2026
Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs) On-Demand Webinar 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
Why the Most Important Phase 3 Decisions Should Be Made Before Phase 3 Blog Why the Most Important Phase 3 Decisions Should Be Made Before Phase 3 Learn how advanced modeling for reimbursement strategy using MBMA and QSP strengthens payer evidence and…CertaraMarch 24, 2026
Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Analysis for Clazakizumab in Patients With End-Stage Kidney Disease Undergoing Dialysis Publication 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 Publication 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 Blog 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