Usage of In Vitro Metabolism Data for Drug-Drug Interaction in Physiologically Based Pharmacokinetic Analysis Submissions to the US Food and Drug Administration
Lee, Jieon, Yang, Yuching, Zhang, Xinyuan, Fan, Jianghong, Grimstein, Manuela, Zhu, Hao, Wang, Yaning
Published in Journal of clinical pharmacology (01.06.2021)
Published in Journal of clinical pharmacology (01.06.2021)
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Journal Article
The Application of Physiologically Based Pharmacokinetic Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory Perspectives
Pan, Yuzhuo, Hsu, Vicky, Grimstein, Manuela, Zhang, Lei, Arya, Vikram, Sinha, Vikram, Grillo, Joseph A, Zhao, Ping
Published in Journal of clinical pharmacology (01.07.2016)
Published in Journal of clinical pharmacology (01.07.2016)
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Journal Article
Utility of Physiologically Based Pharmacokinetic Modeling to Investigate the Impact of Physiological Changes of Pregnancy and Cancer on Oncology Drug Pharmacokinetics
Yang, Xinxin, Grimstein, Manuela, Pressly, Michelle, Fletcher, Elimika Pfuma, Shord, Stacy, Leong, Ruby
Published in Pharmaceutics (01.12.2023)
Published in Pharmaceutics (01.12.2023)
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Journal Article
Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations
Zhang, Xinyuan, Yang, Yuching, Grimstein, Manuela, Liu, Guansheng, Kitabi, Eliford, Fan, Jianghong, Wang, Ying‐Hong, Earp, Justin, Weaver, James L., Zhu, Hao, Liu, Jiang, Reynolds, Kellie S., Huang, Shiew‐Mei, Wang, Yaning
Published in CPT: Pharmacometrics & Systems Pharmacology (01.09.2021)
Published in CPT: Pharmacometrics & Systems Pharmacology (01.09.2021)
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Characterization of Plasma Protein Alterations in Pregnant and Postpartum Individuals Living With HIV to Support Physiologically-Based Pharmacokinetic Model Development
Zhao, Sherry, Gockenbach, Mary, Grimstein, Manuela, Sachs, Hari Cheryl, Mirochnick, Mark, Struble, Kimberly, Belew, Yodit, Wang, Jian, Capparelli, Edmund V., Best, Brookie M., Johnson, Tamara, Momper, Jeremiah D., Maharaj, Anil R.
Published in Frontiers in pediatrics (13.10.2021)
Published in Frontiers in pediatrics (13.10.2021)
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Journal Article
Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA's Office of Clinical Pharmacology
Zhang, Xinyuan, Yang, Yuching, Grimstein, Manuela, Fan, Jianghong, Grillo, Joseph A, Huang, Shiew-Mei, Zhu, Hao, Wang, Yaning
Published in Journal of clinical pharmacology (01.10.2020)
Published in Journal of clinical pharmacology (01.10.2020)
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Journal Article
FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations
Mathieu, Luckson N, Larkins, Erin, Akinboro, Oladimeji, Roy, Pourab, Amatya, Anup K, Fiero, Mallorie H, Mishra-Kalyani, Pallavi S, Helms, Whitney S, Myers, Claire E, Skinner, Amy M, Aungst, Stephanie, Jin, Runyan, Zhao, Hong, Xia, Huiming, Zirkelbach, Jeanne Fourie, Bi, Youwei, Li, Yangbing, Liu, Jiang, Grimstein, Manuela, Zhang, Xinyuan, Woods, Stacie, Reece, Kelie, Abukhdeir, Abdelrahmman M, Ghosh, Soma, Philip, Reena, Tang, Shenghui, Goldberg, Kirsten B, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet
Published in Clinical cancer research (15.01.2022)
Published in Clinical cancer research (15.01.2022)
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Journal Article
Whole Body PBPK Modeling of Remdesivir and Its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients With Organ Dysfunction
Fan, Jianghong, Yang, Yuching, Grimstein, Manuela, Zhang, Xinyuan, Kitabi, Eliford, Earp, Justin C, Arya, Vikram, Reynolds, Kellie S, Zhu, Hao, Wang, Yaning
Published in Clinical pharmacology and therapeutics (01.03.2022)
Published in Clinical pharmacology and therapeutics (01.03.2022)
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Journal Article
Model-Informed Drug Development Approaches to Assist New Drug Development in the COVID-19 Pandemic
Xiong, Ye, Fan, Jianghong, Kitabi, Eliford, Zhang, Xinyuan, Bi, Youwei, Grimstein, Manuela, Yang, Yuching, Earp, Justin C, Zheng, Nan, Liu, Jiang, Wang, Yaning, Zhu, Hao
Published in Clinical pharmacology and therapeutics (01.03.2022)
Published in Clinical pharmacology and therapeutics (01.03.2022)
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Journal Article
Landscape and Regulatory Perspective on Oncology Drugs in Pregnancy
Leong, Ruby, Grimstein, Manuela, DeMaria, Peter, Norsworthy, Kelly J, Fletcher, Elimika Pfuma, Shord, Stacy
Published in Journal of clinical pharmacology (01.06.2023)
Published in Journal of clinical pharmacology (01.06.2023)
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Journal Article
FDA Approval Summary: Asciminib for Ph+ CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the T315I Mutation
Pamuk, Gulsum E., Chow, Edwin C.Y., Ionan, Alexei C., Chen, Haiyan, Lee, Shwu-Luan, Hsu, Vicky, Grimstein, Manuela, Zheng, Nan, Sun, Jielin, Charlab, Rosane, Gehrke, Brenda J., Vallejo, Jonathon, Ehrlich, Lori A., de Claro, R. Angelo, Theoret, Marc R.
Published in Clinical cancer research (16.08.2024)
Published in Clinical cancer research (16.08.2024)
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Journal Article
FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
Telaraja, Deepti, Kasamon, Yvette L, Collazo, Justin S, Leong, Ruby, Wang, Kun, Li, Ping, Dahmane, Elyes, Yang, Yuching, Earp, Justin, Grimstein, Manuela, Rodriguez, Lisa R, Theoret, Marc R, Gormley, Nicole J
Published in Clinical cancer research (05.01.2024)
Published in Clinical cancer research (05.01.2024)
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Journal Article
US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, ESR1 -Mutated Advanced or Metastatic Breast Cancer
Shah, Mirat, Lingam, Hima, Gao, Xin, Gittleman, Haley, Fiero, Mallorie H, Krol, Danielle, Biel, Nikolett, Ricks, Tiffany K, Fu, Wentao, Hamed, Salaheldin, Li, Fang, Sun, Jillian Jielin, Fan, Jianghong, Schuck, Robert, Grimstein, Manuela, Tang, Liuya, Kalavar, Shyam, Abukhdeir, Abdelrahmman, Pathak, Anand, Ghosh, Soma, Bulatao, Ilynn, Tilley, Amy, Pierce, William F, Mixter, Bronwyn D, Tang, Shenghui, Pazdur, Richard, Kluetz, Paul, Amiri-Kordestani, Laleh
Published in Journal of clinical oncology (01.04.2024)
Published in Journal of clinical oncology (01.04.2024)
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FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer
Barbato, Michael I., Bradford, Diana, Ren, Yi, Aungst, Stephanie L., Miller, Claudia P., Pan, Lili, Zirkelbach, Jeanne F., Li, Yangbing, Bi, Youwei, Fan, Jianghong, Grimstein, Manuela, Dorff, Sarah E., Amatya, Anup K., Mishra-Kalyani, Pallavi S., Scepura, Barbara, Schotland, Peter, Udoka, Opeyemi, Ojofeitimi, Idara, Leighton, John K., Rahman, Nam A., Pazdur, Richard, Singh, Harpreet, Kluetz, Paul G., Drezner, Nicole
Published in Clinical cancer research (15.08.2024)
Published in Clinical cancer research (15.08.2024)
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