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

FDA Approval Summary: Datopotamab Deruxtecan-dlnk for Treatment of Patients with Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer

FDA批准摘要:Datopotamab Deruxtecan-dlnk用于治疗不可切除或转移性、HR阳性、HER2阴性乳腺癌患者

Royce, Melanie; Shah, Mirat; Zhang, Lijun; Cheng, Joyce; Bonner, Mary Kate; Pegues, Melissa; Miller, Claudia P; Leu, Lily; Price, Lauren S L; Qiu, Junshan; Yu, Jingyu; Truong, Tien M; Dorff, Sarah E; Yang, Yuching; Zhang, Nailing; Gutierrez-Lugo, Maria; Ricks, Tiffany K; Pierce, William F; Luo, Zhongjun; Kappel, Dana; Goldberg, Kirsten B; Shord, Stacy S; Tang, Shenghui; Bhatnagar, Vishal; Pazdur, Richard; Kluetz, Paul G; Amiri-Kordestani, Laleh

FDA Approval Summary: Tovorafenib for Relapsed or Refractory BRAF-Altered Pediatric Low-Grade Glioma

FDA批准摘要:托沃拉非尼用于治疗复发或难治性BRAF突变型儿童低级别胶质瘤

Singh, Sonia; Bradford, Diana; Chatterjee, Somak; Li, Xiaoxue; Aungst, Stephanie L; Skinner, Amy M; Miller, Claudia P; Kim-McOlash, Sarah; Fourie Zirkelbach, Jeanne; Xiong, Ye; Bi, Youwei; Wang, Ying-Hong; Yang, Yuching; Sun, Jielin; Kraft, Jeffrey; Charlab, Rosane; Shord, Stacy S; Tang, Shenghui; Scepura, Barbara; Bulatao, Ilynn; Udoka, Opeyemi; Saber, Haleh; Rahman, Nam Atiqur; Pazdur, Richard; Singh, Harpreet; Donoghue, Martha; Drezner, Nicole

FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Optimized Dosages for Registrational Trials

FDA-AACR肿瘤药物产品剂量优化策略:注册试验的最佳剂量选择

Shord, Stacy S; Chen, Cong; Jin, Jin Y; Van Wart, Scott; Martin, Sarah K; Davidson, Brad A; Liu, Jiang; LoRusso, Patricia M; Oxnard, Geoffrey R

FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Early-Phase Trials Using Innovative Trial Designs and Biomarkers

FDA-AACR 肿瘤药物产品剂量优化策略:采用创新试验设计和生物标志物的早期试验

Okusanya, Olanrewaju O; Patilea-Vrana, Gabriela I; Sireci, Anthony; Iasonos, Alexia; Davidson, Brad A; Liu, Jiang; Shord, Stacy S; LoRusso, Patricia M; Yap, Timothy A

Dosage Optimization of Pediatric Oncology Products: Our Patients Deserve Better

儿童肿瘤药物剂量优化:我们的患者值得更好的治疗

Wessel, Kristin M; Drezner, Nicole; Shord, Stacy S; Shah, Mirat; Theoret, Marc R; Donoghue, Martha

FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation-Positive Low-Grade Glioma

FDA批准摘要:达拉非尼联合曲美替尼治疗BRAFV600E突变阳性低级别胶质瘤

Barbato, Michael I; Nashed, Jeannette; Bradford, Diana; Ren, Yi; Khasar, Sachia; Miller, Claudia P; Zolnik, Banu S; Zhao, Hong; Li, Yangbing; Bi, Youwei; Shord, Stacy S; Amatya, Anup K; Mishra-Kalyani, Pallavi S; Scepura, Barbara; Al-Matari, Raniya A; Pazdur, Richard; Kluetz, Paul G; Donoghue, Martha; Singh, Harpreet; Drezner, Nicole

Perspectives on Drug Development for the Treatment of Chronic Myeloid Leukemia in Pregnant Patients and Patients Who Are Breastfeeding

针对妊娠期和哺乳期慢性粒细胞白血病患者的药物研发展望

Cortes, Jorge E; Abruzzese, Elisabetta; Cardonick, Elyce H; Hernández-Díaz, Sonia; Gutierrez, Jamie; Sardegna, Mary S; Torres-Chavez, Erica; Dinatale, Miriam; Lerro, Catherine C; Gehrke, Brenda J; Shord, Stacy S; De Claro, R Angelo; Theoret, Marc R; DeMaria, Peter J; Norsworthy, Kelly J

Pediatric Cancer Drug Development: Leveraging Insights in Cancer Biology and the Evolving Regulatory Landscape to Address Challenges and Guide Further Progress

儿童癌症药物研发:利用对癌症生物学和不断变化的监管环境的深刻理解来应对挑战并指导未来的发展

Charlab, Rosane; Leong, Ruby; Shord, Stacy S; Reaman, Gregory H

Utility of Physiologically Based Pharmacokinetic Modeling to Investigate the Impact of Physiological Changes of Pregnancy and Cancer on Oncology Drug Pharmacokinetics

生理药代动力学模型在研究妊娠和癌症生理变化对肿瘤药物药代动力学影响中的应用

Yang, Xinxin; Grimstein, Manuela; Pressly, Michelle; Fletcher, Elimika Pfuma; Shord, Stacy; Leong, Ruby

US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer

美国食品药品监督管理局鼓励利用创新方法来确定癌症患者的最佳剂量。

Shord, Stacy S; Zhu, Hao; Liu, Jiang; Rahman, Atiqur; Booth, Brian; Zineh, Issam