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
Impact of using time-averaged exposure metrics on binary endpoints in exposure-response analyses
This Frontiers in Pharmacology article investigates how using different time-averaged exposure metrics, specifically the time-averaged…
Certara2025 年 1 月 21 日
