IUPHAR review: Computational Psychiatry 2.0. A new tool for supporting combination therapy of psychopharmacology with neuromodulation in schizophrenia Publication IUPHAR review: Computational Psychiatry 2.0. A new tool for supporting combination therapy of psychopharmacology with neuromodulation in schizophrenia Recent clinical trial successes in schizophrenia with non-dopaminergic agents have rejuvenated the field after a…Danielle Pillsbury2025年4月24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,…Danielle Pillsbury2025年3月20日
MIDD in Japan – Implementations, challenges and opportunities Publication MIDD in Japan – Implementations, challenges and opportunities In Japan, there has been a growing adoption of Model Informed Drug Development (MIDD) approaches…Danielle Pillsbury2025年3月12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…Danielle Pillsbury2025年3月4日
Combining mechanistic modeling with machine learning as a strategy to predict inflammatory bowel disease clinical scores Publication 炎症性腸疾患の臨床スコアを予測するための戦略として、機械学習とメカニズムモデリングを組み合わせる In this paper, we discuss a method to integrate simulated markers of inflammation from a…Danielle Pillsbury2025年2月27日
Learn-confirm in model-informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform Publication Learn-confirm in model-informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform Immunogenicity against therapeutic proteins frequently causes attrition owing to its potential impact on pharmacokinetics, pharmacodynamics,…Danielle Pillsbury2025年2月10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
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…Danielle Pillsbury2025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…Danielle Pillsbury2025年1月21日
Management of Vulnerable Patients Hospitalized for COVID-19 With Remdesivir: A Retrospective Comparative Effectiveness Study of Mortality in US Hospitals Publication Management of Vulnerable Patients Hospitalized for COVID-19 With Remdesivir: 米国の病院における死亡率を対象とした、レトロスペクティブ比較研究 Background Coronavirus disease 2019 (COVID-19) remains a major public health concern, with continued resurgences of…Danielle Pillsbury2025年1月16日