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US Food and Drug Administration regulatory updates in neuro-oncology

Journal of neuro-oncology, 2021-07, Vol.153 (3), p.375-381

2021

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Realizing the promise of Project Optimus: Challenges and emerging opportunities for dose optimization in oncology drug development

CPT: pharmacometrics and systems pharmacology, 2024-05, Vol.13 (5), p.691-709

2024

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CDK4/6 Inhibitors: Game Changers in the Management of Hormone Receptor–Positive Advanced Breast Cancer?

Oncology (Williston Park, N.Y.), 2018-05, Vol.32 (5), p.216-222

2018

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The Drug-Dosing Conundrum in Oncology — When Less Is More

The New England journal of medicine, 2021-10, Vol.385 (16), p.1445-1447

2021

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Dosage Optimization: A Regulatory Perspective for Developing Oncology Drugs

Clinical pharmacology and therapeutics, 2024-09, Vol.116 (3), p.577-591

2024

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Improving Dose-Optimization Processes Used in Oncology Drug Development to Minimize Toxicity and Maximize Benefit to Patients

Journal of clinical oncology, 2022-10, Vol.40 (30), p.3489-3500

2022

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Talking to the FDA about dose optimization and the aims of Project Optimus

Clinical advances in hematology & oncology, 2022-03, Vol.20 (3), p.148

2022

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FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer

Clinical cancer research, 2022-12, Vol.28 (24), p.5249-5253

2022

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

Clinical cancer research, 2023-10, Vol.29 (19), p.3835-3840

2023

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Dosage optimization in drug development: An FDA Project Optimus analysis of postmarketing requirements issued to repair the cracks

Journal of clinical oncology, 2023-06, Vol.41 (16_suppl), p.1598-1598

2023

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U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review

Clinical cancer research, 2022-03, Vol.28 (6), p.1072-1086

2022

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A trainee-led quality improvement project to improve rates of palliative care utilization in patients with advanced cancer

Journal of clinical oncology, 2019-09, Vol.37 (27_suppl), p.51-51

2019

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FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-positive Breast Cancer

Clinical cancer research, 2021-03, Vol.27 (5), p.1220-1226

2021

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Asking Matters Most: Depression in Advanced Cancer

Oncology (Williston Park, N.Y.), 2019-02, Vol.33 (2), p.64

2019

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Abstract P6-10-07: Activating HER2 missense mutations in HER2-negative metastatic breast cancer

Cancer research (Chicago, Ill.), 2020-02, Vol.80 (4_Supplement), p.P6-P6-10-07

2020

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FDA approval summary: fam-trastuzumab deruxtecan-nxki for unresectable or metastatic non-small cell lung cancer with activating HER2 mutations

The oncologist (Dayton, Ohio), 2024-08, Vol.29 (8), p.667-671

2024

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U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review

Clinical cancer research, 2022-03, Vol.28 (6), p.1058-1071

2022

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Piloting workshops to enhance hope among patients with advanced breast cancer and oncologists

Journal of clinical oncology, 2019-11, Vol.37 (31_suppl), p.137-137

2019

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Olaparib Use in Patients With Metastatic Breast Cancer Harboring Somatic BRCA1/2 Mutations or Mutations in Non-BRCA1/2, DNA Damage Repair Genes

Clinical breast cancer, 2022-06, Vol.22 (4), p.319-325

2022

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A Phase I Study of Dinaciclib in Combination With MK‐2206 in Patients With Advanced Pancreatic Cancer

Clinical and translational science, 2020-11, Vol.13 (6), p.1178-1188

2020

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Prevention of influenza in healthy children

Expert review of anti-infective therapy, 2012-10, Vol.10 (10), p.1139-1152

2012

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The Economic Value of a Visceral Leishmaniasis Vaccine in Bihar State, India

The American journal of tropical medicine and hygiene, 2012-03, Vol.86 (3), p.417-425

2012

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The Johns Hopkins Hope at Hopkins Clinic: Supporting the comprehensive needs of individuals with metastatic breast cancer

JCO oncology practice, 2023-11, Vol.19 (11_suppl), p.452-452

2023

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Developing Workshops to Enhance Hope Among Patients With Metastatic Breast Cancer and Oncologists: A Pilot Study

JCO oncology practice, 2021-06, Vol.17 (6), p.e785-e793

2021

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US Food and Drug Administration regulatory updates in neuro-oncology

Realizing the promise of Project Optimus: Challenges and emerging opportunities for dose optimization in oncology drug development

CDK4/6 Inhibitors: Game Changers in the Management of Hormone Receptor–Positive Advanced Breast Cancer?

The Drug-Dosing Conundrum in Oncology — When Less Is More

Dosage Optimization: A Regulatory Perspective for Developing Oncology Drugs

Improving Dose-Optimization Processes Used in Oncology Drug Development to Minimize Toxicity and Maximize Benefit to Patients

Talking to the FDA about dose optimization and the aims of Project Optimus

FDA Approval Summary: Pembrolizumab for Neoadjuvant and Adjuvant Treatment of Patients with High-Risk Early-Stage Triple-Negative Breast Cancer

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

Dosage optimization in drug development: An FDA Project Optimus analysis of postmarketing requirements issued to repair the cracks

U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review

A trainee-led quality improvement project to improve rates of palliative care utilization in patients with advanced cancer

FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-positive Breast Cancer

Asking Matters Most: Depression in Advanced Cancer

Abstract P6-10-07: Activating HER2 missense mutations in HER2-negative metastatic breast cancer

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

FDA approval summary: fam-trastuzumab deruxtecan-nxki for unresectable or metastatic non-small cell lung cancer with activating HER2 mutations

U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review

Piloting workshops to enhance hope among patients with advanced breast cancer and oncologists

Olaparib Use in Patients With Metastatic Breast Cancer Harboring Somatic BRCA1/2 Mutations or Mutations in Non-BRCA1/2, DNA Damage Repair Genes

A Phase I Study of Dinaciclib in Combination With MK‐2206 in Patients With Advanced Pancreatic Cancer

Prevention of influenza in healthy children

The Economic Value of a Visceral Leishmaniasis Vaccine in Bihar State, India

The Johns Hopkins Hope at Hopkins Clinic: Supporting the comprehensive needs of individuals with metastatic breast cancer

Developing Workshops to Enhance Hope Among Patients With Metastatic Breast Cancer and Oncologists: A Pilot Study

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