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…Certara2026 年 3 月 24 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
ICH M15 Guideline: What the Finalized Guideline Means for Model-Informed Drug Development Blog ICH M15 Guideline: What the Finalized Guideline Means for Model-Informed Drug Development With the release of the draft ICH M15 guidance, MIDD is no longer optional -…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
Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer Publication Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer This study used model-based meta-analysis (MBMA) to assess how well objective response rate (ORR) predicts…Danielle Pillsbury2026 年 3 月 4 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
Apotekarsocieteten Clinical Pharmacology Strategies in Drug Development Conference Apotekarsocieteten 临床药理学策略在药物开发中的应用 Danielle Pillsbury2026 年 3 月 2 日