Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning Publication Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning Due to the highly controlled settings of clinical trials, enrolled subjects may not be fully…Danielle Pillsbury2025年6月19日
From Data to Decisions: Real-World Impact of Model-Based Meta-Analysis (MBMA) with GSK and Certara Webinar From Data to Decisions: Real-World Impact of Model-Based Meta-Analysis (MBMA) with GSK and Certara Certara2025年6月18日
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
Gene Therapy: A Transformative Shift in Rare Disease Treatment Video Gene Therapy: A Transformative Shift in Rare Disease Treatment After decades of promise, gene therapy is finally starting to deliver on its potential—especially for…Certara2025年2月26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
Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters Blog Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters 2025年1月10日 Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A…Certara2025年1月10日
Preclinical data exposures underpredict clinical physiologically active doses for bispecific T-cell engagers in solid tumors indications; are there better metrics? -insights from a small mechanistic MBMA Poster Preclinical data exposures underpredict clinical physiologically active doses for bispecific T-cell engagers in solid tumors indications; are there better metrics? -insights from a small mechanistic MBMA Certara2024年12月11日
Simultaneous Population PKPD Analysis of Belantamab Mafodotin, Soluble BCMA, and Serum M-Protein in Subjects With Relapsed/Refractory Multiple Myeloma Poster Simultaneous Population PKPD Analysis of Belantamab Mafodotin, Soluble BCMA, and Serum M-Protein in Subjects With Relapsed/Refractory Multiple Myeloma Certara2024年11月22日
A Pharmacokinetic Analysis of Drug Concentration Using a Novel Deep Learning Model Poster A Pharmacokinetic Analysis of Drug Concentration Using a Novel Deep Learning Model Certara2024年11月22日
Model-Informed Drug Development Framework for the Development and Dose Optimization of Targeted Radiation Therapies Poster モデルを活かした医薬品開発(MIDD)の枠組みによる、標的放射線療法の開発と投与量の最適化 Certara2024年11月22日