MIDD in Japan – Implementations, challenges and opportunities
In Japan, there has been a growing adoption of Model Informed Drug Development (MIDD) approaches…
Certara2025年3月12日
Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach
This study explores a model-based meta-analysis (MBMA) and a clinical utility index (CUI) approach to…
Certara2025年3月4日
Machine Learning for PK/PD Modeling in Drug Development
Pharmacometricians can use machine learning for PK/PD modeling to help them characterize the safety and…
Certara2025年3月4日
How the US FDA MIDD paired pilot program helps sponsors
2025年2月28日 For the past couple of decades, leading American institutions, pharmaceutical and biotechnology…
Certara2025年2月28日
The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement
This article explores the overlooked yet critical role of early strategic planning for payer reimbursement…
Certara2025年2月25日
Machine Learning for Population PK Model Selection: Theory and Practice
Three of Certara's expert modelers provide a gentle introduction to machine learning in our field.…
Certara2025年2月7日
Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies
This study conducted a population pharmacokinetic (PK) and pharmacodynamic (PD) analysis of navtemadlin, an MDM2…
Certara2025年2月6日
Understanding Variability in CAR-T Cell Therapy Kinetics
Axicabtagene ciloleucel (axi-cel), a CAR-T cell therapy for relapsed and refractory non-Hodgkin’s lymphoma (NHL), demonstrates…
Certara2025年1月23日
