Mirat Shah - Center for Drug Evaluation and Research (CDER), US Food and Drug Administration

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论文共 29 篇作者统计合作学者相似作者

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The Johns Hopkins Hope at Hopkins Clinic: Supporting the Comprehensive Needs of Individuals with Metastatic Breast Cancer

Vered Stearns,Ruizhe Chen,Amanda L. Blackford,Elizabeth Saylor, Jill Mull, Ann Folmer,Jessica Jelinek,Christine Hodgdon, Jacqueline Bacon,Jessica Engle,Mirat Shah, Rosanne Sheinberg,Sandra Pedraza-Cardozo,Mary Wilkinson,Melissa Alvendia,Claire Snyder,Karen L. Smith

Breast Cancer Research and Treatment（2025）

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Realizing the Promise of Project Optimus: Challenges and Emerging Opportunities for Dose Optimization in Oncology Drug Development

Wei Gao,Jiang Liu, Blerta Shtylla,Karthik Venkatakrishnan,Donghua Yin,Mirat Shah,Timothy Nicholas,Yanguang Cao

CPT Pharmacometrics & Systems Pharmacology（2024）

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FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for Unresectable or Metastatic Non-Small Cell Lung Cancer with Activating HER2 Mutations

Gautam U. Mehta,Paz J. Vellanki, Yi Ren,Anup K. Amatya,Pallavi S. Mishra-Kalyani, Lili Pan,Jeanne F. Zirkelbach,Yuzhuo Pan,Jiang Liu,Stephanie L. Aungst,Claudia P. Miller,Mirat Shah,Nam Atiqur Rahman,Marc Theoret,Paul Kluetz,Richard Pazdur,Julia A. Beaver,Harpreet Singh

The Oncologist (2024)

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Dosage Optimization: A Regulatory Perspective for Developing Oncology Drugs

Atiqur Rahman,Mirat Shah,Stacy S. Shord

Clinical Pharmacology &amp Therapeutics (2024)

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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

Mirat Shah, Hima Lingam, Xin Gao,Haley Gittleman,Mallorie H. Fiero,Danielle Krol, Nikolett Biel,Tiffany K. Ricks,Wentao Fu,Salaheldin Hamed, Fang Li, Jillian (Jielin) Sun,Jianghong Fan,Robert Schuck,Manuela Grimstein, Liuya Tang,Shyam Kalavar, Abdelrahmman Abukhdeir,Anand Pathak,Soma Ghosh,Ilynn Bulatao,Amy Tilley,William F. Pierce,Bronwyn D. Mixter,Shenghui Tang,Richard Pazdur,Paul Kluetz,Laleh Amiri-Kordestani

JOURNAL OF CLINICAL ONCOLOGY（2024）

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Relationship of HIF-1α and Tumor Infiltrating Lymphocytes in Patients with HER2-negative Early-Stage Breast Cancer Treated with Neoadjuvant Chemotherapy

Harsh Oza,Victoria Grabinski, Hector Ibanez,Ines Godet,Daniele Gilkes,Ashley Cimino-Mathews,Edward Gabrielson,Mirat Shah,W. Iris Zhi,Zoe Pipa,Jennifer Lehman,Suqi Ke,Hua-Ling Tsai,Vered Stearns,Cesar Augusto Santa-Maria

CANCER RESEARCH（2023）

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Dosage Optimization in Drug Development: an FDA Project Optimus Analysis of Postmarketing Requirements Issued to Repair the Cracks

Brian Heiss,Lili Pan,Alemayehu Akalu,Jonathon Vallejo,Joyce Cheng,Pamela Balcazar,Nam Atiqur Rahman,Stacy Shifflett Shord,Mirat Shah,Richard Pazdur,Marc Theoret

JOURNAL OF CLINICAL ONCOLOGYno. 16 (2023)

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FDA Approval Summary: Mirvetuximab Soravtansine-Gynx for FRα-Positive, Platinum-Resistant Ovarian Cancer

CLINICAL CANCER RESEARCHno. 19 (2023): 3835-3840

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Abstract P2-20-14: Relationship of HIF-1α and Tumor Infiltrating Lymphocytes in Patients with HER2-negative Early-Stage Breast Cancer Treated with Neoadjuvant Chemotherapy

Cancer Researchno. 5_Supplement (2023): P2-20

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