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,…Danielle Pillsbury2025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…Danielle Pillsbury2025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 Danielle Pillsbury2024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 Danielle Pillsbury2024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 Danielle Pillsbury2024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 Danielle Pillsbury2024年11月22日
Oncology MIDD Simulator, A User-Friendly Application for Overall Survival Forecasting in Early Oncology Trials Poster Oncology MIDD Simulator, A User-Friendly Application for Overall Survival Forecasting in Early Oncology Trials Danielle Pillsbury2024年11月22日
Population pharmacokinetic modeling of niraparib to assess different absorption models Poster Population pharmacokinetic modeling of niraparib to assess different absorption models Danielle Pillsbury2024年11月22日