From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs
New CPT review by Certara's Karen Rowland Yeo & Piet van der Graaf shows how…
Danielle Pillsbury2026 年 9 月 23 日
Modeling effective doses of therapeutic antibodies targeting clustered surface receptors
Discover how semi-mechanistic PK/receptor-occupancy modeling reveals that lower, subcutaneous doses, not maximum tolerated doses, optimize…
Danielle Pillsbury2026 年 9 月 23 日
A glimpse into the future of model-informed drug discovery and development
Explore the future of Model-Informed Drug Development (MIDD), including advances in pharmacometrics, PBPK, QSP, precision…
Certara2026 年 8 月 28 日
Refinement of Operating Characteristics for Model-Based TGI Metrics Decision Support to Ungate a Pivotal Trial in Oncology
Explore how model-based tumor growth inhibition metrics can support earlier Go/No-Go decisions and pivotal trial…
Certara2026 年 8 月 28 日
Population Pharmacokinetic Modeling of Niraparib to Assess Different Absorption Models
This publication describes the development of an updated population pharmacokinetic (PopPK) model for niraparib, a…
Certara2026 年 5 月 21 日
Beyond approval: Using model-informed strategies to maximize the value of ADCs
Discover how model-informed drug development for ADCs integrates modeling, clinical data, and real-world evidence to…
Certara2026 年 4 月 28 日
ADC dose optimization: Applying model-informed strategies in development
Explore ADC dose optimization using model-informed strategies to balance efficacy and safety across antibody drug…
Certara2026 年 4 月 22 日
Model-Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated HNSCC: A QSP Model for Alpelisib and Tipifarnib Combination
This study showcases how quantitative systems pharmacology (QSP) and model-informed drug development (MIDD) can transform…
Danielle Pillsbury2026 年 3 月 25 日
ADC first-in-human (FIH) dose selection: Designing FIH studies for success
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
Adaptive clinical trials in oncology: Meeting the challenge of Project Optimus
Leveraging adaptive clinical trial designs in oncology can accelerate drug development, while following the FDA…
Certara2026 年 1 月 16 日
