Machine Learning for PK/PD Modeling in Drug Development Blog 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…CertaraMarch 4, 2025
How the US FDA MIDD paired pilot program helps sponsors Blog How the US FDA MIDD paired pilot program helps sponsors February 28, 2025 For the past couple of decades, leading American institutions, pharmaceutical and biotechnology…CertaraFebruary 28, 2025
The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement Publication 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…CertaraFebruary 25, 2025
Simulations to Inform Dose Selection for a Phase 2b Trial Investigating TOUR006, a Fully Human Anti-IL6 Antibody, for Treatment of Thyroid Eye Disease Poster Simulations to Inform Dose Selection for a Phase 2b Trial Investigating TOUR006, a Fully Human Anti-IL6 Antibody, for Treatment of Thyroid Eye Disease CertaraFebruary 7, 2025
Machine Learning for Population PK Model Selection: Theory and Practice On-Demand Webinar 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.…CertaraFebruary 7, 2025
Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies Publication 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…CertaraFebruary 6, 2025
Understanding Variability in CAR-T Cell Therapy Kinetics Publication 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…CertaraJanuary 23, 2025
Impact of using time-averaged exposure metrics on binary endpoints in exposure-response analyses Publication 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…CertaraJanuary 21, 2025
Solving Drug Development Challenges with Model-Based Meta-Analysis (MBMA) On-Demand Webinar Solving Drug Development Challenges with Model-Based Meta-Analysis (MBMA) In this on-demand webinar, "MBMA: Optimizing Drug Development with Aggregate Clinical Trial Data and Predictive…CertaraJanuary 9, 2025
INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer’s disease Publication INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer’s disease The Phase 1 INTERCEPT-AD study evaluated sabirnetug (ACU193), a monoclonal antibody targeting amyloid-beta oligomers (AβOs),…CertaraJanuary 8, 2025