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 HIV感染でウイルス学的に抑制されている思春期患者における、長時間作用型注射剤カボテグラビルと長時間作用型注射剤リルピビリンの併用療法の安全性(IMPAACT 2017/MOCHA):第1/2相、多施設共同、オープンラベル、非比較、用量設定試験 The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…Certara2025年3月20日
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…Certara2025年3月14日
Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach Publication 抗体薬物複合体の市販後評価:モデルに基づくメタ解析 (MBMA) および臨床有用性指数アプローチを用いた概念実証 This study explores a model-based meta-analysis (MBMA) and a clinical utility index (CUI) approach to…Certara2025年3月4日
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…Certara2025年2月25日
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 バセドウ病眼症の治療を目的とした完全ヒト型抗IL-6抗体TOUR006のフェーズ2b試験における用量選択を支援するためのシミュレーション 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 Publication 再発または難治性の骨髄線維症およびその他の骨髄系・固形腫瘍を対象としたNavtemadlinの集団薬物動態・薬力学解析 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 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…Certara2025年1月23日
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…Certara2025年1月21日
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…Certara2025年1月9日