Mechanistic Modeling Guides Bispecific Antibody Design and Target Selection for Maximizing Therapeutic Window Poster 机制建模指导双特异性抗体设计和靶标选择,最大限度地扩大治疗窗口 Therapeutic antibodies have shown promise in treating diseases such as cancer, but selectivity remains a…Danielle Pillsbury2025 年 3 月 28 日
QSP Modeling Optimizes FIH Dose Selection for Multiple Myeloma Therapy Case Study QSP 建模优化多发性骨髓瘤疗法的首次人体试验剂量选择 Multiple myeloma, the second most common blood cancer, affects an estimated 160,000 individuals annually worldwide…Danielle Pillsbury2025 年 3 月 25 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 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,…Danielle Pillsbury2025 年 3 月 20 日
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…Danielle Pillsbury2025 年 3 月 4 日
Rare Oncology Product Launch Playbook: Universal Strategies for Success in the U.S. and Europe White Paper 罕见肿瘤学产品发布手册:在美国和欧洲取得成功的通用策略 Lorem ipsum dolor sit amet consectetur. At venenatis urna sapien ut lorem enim. Morbi lectus…Danielle Pillsbury2025 年 2 月 28 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 针对复发难治性(R/R)骨髓纤维化(MF)及其他髓系或实体瘤恶性肿瘤患者的 Navtemadlin 群体药代动力学与药效学分析 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 了解 CAR-T 细胞疗法动力学的变异性 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
Simultaneous Population PKPD Analysis of Belantamab Mafodotin, Soluble BCMA, and Serum M-Protein in Subjects With Relapsed/Refractory Multiple Myeloma Poster 复发/难治性多发性骨髓瘤患者 Belantamab Mafodotin、可溶性B细胞成熟抗原(BCMA)和血清 M-蛋白的群体药代动力学-药效学(PKPD)同步分析 Danielle Pillsbury2024 年 11 月 22 日
A Pharmacokinetic Analysis of Drug Concentration Using a Novel Deep Learning Model Poster 利用新型深度学习模型进行药物浓度的药代动力学分析 Danielle Pillsbury2024 年 11 月 22 日
Model-Informed Drug Development Framework for the Development and Dose Optimization of Targeted Radiation Therapies Poster 用于开发和优化靶向辐射疗法剂量的模型引导的药物开发框架 Danielle Pillsbury2024 年 11 月 22 日