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 Pillsbury2026 年 4 月 2 日
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…Certara2026 年 3 月 26 日
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 Pillsbury2026 年 3 月 24 日
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…Certara2026 年 3 月 24 日
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…Certara2026 年 3 月 24 日
What is GLP (Good Laboratory Practice)? BlogKnowledge Base What is GLP (Good Laboratory Practice)? Read this blog to understand GLP (Good Laboratory Practice) and associated QA audits, and proper…Certara2026 年 3 月 18 日
Advancing pharmacoequity through model-informed drug development: Insights from ASCPT 2026 Blog Advancing pharmacoequity through model-informed drug development: Insights from ASCPT 2026 Explore how model-informed drug development and AI are advancing pharmacoequity and shaping the future of…Certara2026 年 3 月 11 日
ADC First-in-Human (FIH) Dose Selection: Designing FIH Studies for Success Blog ADC 首次人体(FIH)剂量选择:成功设计 FIH 研究的关键 Optimize ADC First-in-Human Dose Selection with model-informed strategies and exposure–response insights to design safer, more…Certara2026 年 3 月 3 日
Start right, finish strong: Antibody-drug conjugate (ADC) studies for success On-Demand Webinar Start right, finish strong: 抗体-药物偶联物(ADC)研究成功之道 Learn how to build regulatory-ready first-in-human (FIH) dose strategies for antibody-drug conjugates (ADCs). Discover how…Certara2026 年 2 月 23 日
FAQs: The ICH M15 Guideline and What It Means for Model-Informed Drug Development Blog FAQs: The ICH M15 Guideline and What It Means for Model-Informed Drug Development Learn what the ICH M15 guideline means for Model-Informed Drug Development, regulatory credibility, harmonization, and…Certara2026 年 2 月 18 日