Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study Publication Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…CertaraMarch 20, 2025
How biosimulation and virtual trials can bust through clinical trial roadblocks Press Coverage How biosimulation and virtual trials can bust through clinical trial roadblocks Discover how using biosimulation for rare disease drug development can help overcome statistical and recruitment…CertaraMarch 14, 2025
Behind the Science: A Conversation with Katrina Hui Video Behind the Science: A Conversation with Katrina Hui CertaraMarch 5, 2025
Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach Publication 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…CertaraMarch 4, 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
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