日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:

Model-based meta-analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus

基于潜在变量模型的模型荟萃分析为系统性红斑狼疮的新疗法设定基准

Goteti, Kosalaram; Garcia, Ramon; Gillespie, William R; French, Jonathan; Klopp-Schulze, Lena; Li, Ying; Mateo, Cristina Vazquez; Roy, Sanjeev; Guenther, Oliver; Benincosa, Lisa; Venkatakrishnan, Karthik

Asia-inclusive drug development leveraging principles of ICH E5 and E17 guidelines: Case studies illustrating quantitative clinical pharmacology as a foundational enabler

以ICH E5和E17指南原则为基础,开展包容亚洲的药物研发:案例研究阐明定量临床药理学作为基础推动因素的作用

Lu, Hong; Klopp-Schulze, Lena; Mukker, Jatinder Kaur; Li, Dandan; Kuroki, Yoshihiro; Bolleddula, Jayaprakasam; Terranova, Nadia; Goteti, Kosalaram; Gao, Wei; Strotmann, Rainer; Dong, Jennifer; Venkatakrishnan, Karthik

Safety, Tolerability, and Pharmacodynamics of the ADAMTS-5 Nanobody M6495: Two Phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled Studies in Healthy Subjects and Patients With Osteoarthritis

ADAMTS-5纳米抗体M6495的安全性、耐受性和药效学:两项在健康受试者和骨关节炎患者中进行的I期单中心双盲随机安慰剂对照研究

Bihlet, Asger Reinstrup; Balchen, Torben; Goteti, Kosalaram; Sonne, Jesper; Ladel, Christoph; Karsdal, Morten Asser; Ona, Victor; Moreau, Flavie; Waterhouse, Roseann; Bay-Jensen, Anne-Christine; Guehring, Hans

Disease trajectory of SLE clinical endpoints and covariates affecting disease severity and probability of response: Analysis of pooled patient-level placebo (Standard-of-Care) data to enable model-informed drug development

系统性红斑狼疮(SLE)临床终点及影响疾病严重程度和疗效概率的协变量的疾病轨迹:汇总患者水平安慰剂(标准治疗)数据分析,以支持基于模型的药物研发

Goteti, Kosalaram; French, Jonathan; Garcia, Ramon; Li, Ying; Casset-Semanaz, Florence; Aydemir, Aida; Townsend, Robert; Mateo, Cristina Vazquez; Studham, Matthew; Guenther, Oliver; Kao, Amy; Gastonguay, Marc; Girard, Pascal; Benincosa, Lisa; Venkatakrishnan, Karthik

Applying Modeling and Simulations for Rational Dose Selection of Novel Toll-Like Receptor 7/8 Inhibitor Enpatoran for Indications of High Medical Need

应用建模和仿真技术对新型 Toll 样受体 7/8 抑制剂恩帕托兰进行合理剂量选择,以满足高度医疗需求。

Klopp-Schulze, Lena; Shaw, Jamie V; Dong, Jennifer Q; Khandelwal, Akash; Vazquez-Mateo, Cristina; Goteti, Kosalaram

Designing phase I oncology dose escalation using dose-exposure-toxicity models as a complementary approach to model-based dose-toxicity models

利用剂量-暴露-毒性模型设计I期肿瘤剂量递增方案,作为基于模型的剂量-毒性模型的补充方法

Pantoja, Kristyn; Lanke, Shankar; Munafo, Alain; Victor, Anja; Habermehl, Christina; Schueler, Armin; Venkatakrishnan, Karthik; Girard, Pascal; Goteti, Kosalaram

To blind or not to blind first in human and exploratory clinical trials: Acceleration of development vs. risk of bias

在人体和探索性临床试验中,是否首先采用盲法:加速研发与偏倚风险

Haertter, Sebastian; Kanodia, Jitendar; Cook, Jack; Alicea, Jeanette; Brennan, Bonnie J; Desai, Amit; Patel, Bela; Pan, Lin; Goteti, Kosalaram

Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations

包括关键性VISION试验患者在内的MET抑制剂tepotinib的暴露-反应分析:支持剂量建议

Xiong, Wenyuan; Hietala, Sofia Friberg; Nyberg, Joakim; Papasouliotis, Orestis; Johne, Andreas; Berghoff, Karin; Goteti, Kosalaram; Dong, Jennifer; Girard, Pascal; Venkatakrishnan, Karthik; Strotmann, Rainer

Phase 1 study in healthy participants of the safety, pharmacokinetics, and pharmacodynamics of enpatoran (M5049), a dual antagonist of toll-like receptors 7 and 8

一项针对健康受试者的 I 期研究,旨在评估 Enpatoran (M5049)(一种 Toll 样受体 7 和 8 的双重拮抗剂)的安全性、药代动力学和药效学。

Port, Andreas; Shaw, Jamie V; Klopp-Schulze, Lena; Bytyqi, Afrim; Vetter, Claudia; Hussey, Elizabeth; Mammasse, Nadra; Ona, Victor; Bachmann, Angelika; Strugala, Denis; Reh, Christian; Goteti, Kosalaram

Comparison of Various Phase I Combination Therapy Designs in Oncology for Evaluation of Early Tumor Shrinkage Using Simulations

利用模拟方法比较肿瘤学中各种 I 期联合治疗方案对早期肿瘤缩小效果的影响

Seurat, Jérémy; Girard, Pascal; Goteti, Kosalaram; Mentré, France