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

FDA Approval Summary: Lisocabtagene Maraleucel for Relapsed or Refractory Follicular Lymphoma

FDA批准摘要:Lisocabtagene Maraleucel用于治疗复发或难治性滤泡性淋巴瘤

Britton, Kristen; Mahat, Upendra; Richardson, Nicholas C; Tegenge, Million; Gao, Qianmiao; Theoret, Marc R; Fashoyin-Aje, Lola A

FDA Approval Summary: Lifileucel for Unresectable or Metastatic Melanoma Previously Treated with an Anti-PD-1-Based Immunotherapy

FDA批准摘要:Lifileucel用于治疗既往接受过抗PD-1免疫疗法治疗的不可切除或转移性黑色素瘤

Hu, Lianne; Fan, Chaohong; Bross, Peter; Das, Asha; Cho, Elin S; Knudson, Karin M; Tegenge, Million; Gao, Qianmiao; Brewer, Jamie R; Theoret, Marc R; Fashoyin-Aje, Lola A

Physiologically Based Pharmacokinetic Modeling and Simulation in Regulatory Review: US FDA CBER Experience and Perspectives

基于生理的药代动力学建模与模拟在监管审查中的应用:美国FDA CBER的经验与展望

Tegenge, Million A; Yogurtcu, Osman N; Belov, Artur A; Wang, Xiaofei; Forshee, Richard A

Utilization of Machine Learning Approaches for Drug Clearance Prediction and Population Pharmacokinetic Covariate Analysis

利用机器学习方法进行药物清除率预测和群体药代动力学协变量分析

Rawal, Atul; Ou, Jiayi; Zhu, Hao; Sauna, Zuben; Tegenge, Million A

Physiologically Based Pharmacokinetic Model for Prediction of Immunoglobulins Exposure in Pregnant Women

基于生理的药代动力学模型预测孕妇免疫球蛋白暴露量

Tegenge, Million A

Pharmacokinetics and Efficacy of Human Hyperimmune Intravenous Immunoglobulin Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 Infection in Adult Syrian Hamsters

人高免疫球蛋白静脉注射治疗严重急性呼吸综合征冠状病毒2感染在成年叙利亚仓鼠中的药代动力学和疗效

Stauft, Charles B; Tegenge, Million; Khurana, Surender; Lee, Youri; Selvaraj, Prabhuanand; Golding, Hana; Wang, Tony; Golding, Basil

Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making

综述:模型指导的药物开发方法在药物开发生命周期和监管决策中的作用

Madabushi, Rajanikanth; Seo, Paul; Zhao, Liang; Tegenge, Million; Zhu, Hao

Opportunities and challenges for applying model-informed drug development approaches to gene therapies

将模型指导的药物开发方法应用于基因治疗的机遇与挑战

Belov, Artur; Schultz, Kimberly; Forshee, Richard; Tegenge, Million A

Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision-making-A workshop summary

制定基于生理的药代动力学模型最佳实践以支持临床药理学监管决策——研讨会总结

Jean, Daphney; Naik, Kunal; Milligan, Lauren; Hall, Stephen; Mei Huang, Shiew; Isoherranen, Nina; Kuemmel, Colleen; Seo, Paul; Tegenge, Million A; Wang, Yaning; Yang, Yuching; Zhang, Xinyuan; Zhao, Liang; Zhao, Ping; Benjamin, Jessica; Bergman, Kimberly; Grillo, Joseph; Madabushi, Rajanikanth; Wu, Fang; Zhu, Hao; Zineh, Issam

Dosing Considerations for Antibodies Against COVID-19

新冠病毒抗体剂量注意事项

Tegenge, Million A; Mahmood, Iftekhar; Struble, Evi; Golding, Basil