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Post-Approval Drug Safety Surveillance

Annual review of public health, 2010-01, Vol.31 (1), p.419-437

2010

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

Clinical cancer research, 2024-01, Vol.30 (2), p.263

2024

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FDA Approval Summary: Selpercatinib for the treatment of advanced RET fusion-positive solid tumors

Clinical cancer research, 2023-09, Vol.29 (18), p.3573-3578

2023

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FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint Inhibitors for the Treatment of Biliary Tract Cancer

Clinical cancer research, 2024-08, Vol.30 (16), p.3371-3377

2024

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FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Clinical cancer research, 2023-02, Vol.29 (3), p.508-512

2023

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Improving Collection and Analysis of Overall Survival Data

Clinical cancer research, 2024-09, Vol.30 (18), p.3974-3982

2024

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Statistical Methods for Drug Safety

1st, 2015

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Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples

Clinical cancer research, 2021-11, Vol.27 (21), p.5753-5756

2021

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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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FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer

Clinical cancer research, 2024-08, Vol.30 (16), p.3364-3370

2024

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FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors

Clinical cancer research, 2023-09, Vol.29 (18), p.3573-3578

2023

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Implementation of a Depression Screening Protocol and Tools to Improve Screening for Depression in Patients With Diabetes in the Primary Care Setting

Journal for nurse practitioners, 2016-11, Vol.12 (10), p.690-696

2016

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Deficits in Complex Motor Functions, Despite No Evidence of Procedural Learning Deficits, Among HIV+ Individuals With History of Substance Dependence

Neuropsychology, 2008-11, Vol.22 (6), p.776-786

2008

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Mixed-effects Poisson regression analysis of adverse event reports: The relationship between antidepressants and suicide

Statistics in medicine, 2008-05, Vol.27 (11), p.1814-1833

2008

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FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAF V600E Mutation–Positive Low-Grade Glioma

Clinical cancer research, 2024-01, Vol.30 (2), p.263-268

2024

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Implementation of a Depression Screening Protocol and Tools to Improve Screening for Depression in Patients With Diabetes in the Primary Care Setting

Journal for nurse practitioners, 2016-10, Vol.12 (9), p.690-696

2016

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Sample Size Determination for Multilevel Hierarchical Designs Using Generalized Linear Mixed Models

Biometrics, 2018-06, Vol.74 (2), p.673-684

2018

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Efferent-induced alterations in distortion and reflection otoacoustic emissions in children

The Journal of the Acoustical Society of America, 2018-02, Vol.143 (2), p.640-644

2018

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Meta-Analysis of Rare Binary Adverse Event Data

Journal of the American Statistical Association, 2012-06, Vol.107 (498), p.555-567

2012

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Methodology for Good Machine Learning with Multi‐Omics Data

Clinical pharmacology and therapeutics, 2024-04, Vol.115 (4), p.745-757

2024

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Fat Phobias Held by High School Students in Mexico and Thailand

Research quarterly for exercise and sport, 2014-03, Vol.85 (S1), p.A83

2014

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Likelihood-Based Random-Effect Meta-Analysis of Binary Events

Journal of biopharmaceutical statistics, 2015-09, Vol.25 (5), p.984-1004

2015

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Post-Approval Drug Safety Surveillance

FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations

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

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

FDA Approval Summary: Selpercatinib for the treatment of advanced RET fusion-positive solid tumors

FDA Approval Summary: Durvalumab and Pembrolizumab, Immune Checkpoint Inhibitors for the Treatment of Biliary Tract Cancer

FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer

Improving Collection and Analysis of Overall Survival Data

Statistical Methods for Drug Safety

Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples

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

FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer

FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors

Implementation of a Depression Screening Protocol and Tools to Improve Screening for Depression in Patients With Diabetes in the Primary Care Setting

Deficits in Complex Motor Functions, Despite No Evidence of Procedural Learning Deficits, Among HIV+ Individuals With History of Substance Dependence

Mixed-effects Poisson regression analysis of adverse event reports: The relationship between antidepressants and suicide

FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAF V600E Mutation–Positive Low-Grade Glioma

Implementation of a Depression Screening Protocol and Tools to Improve Screening for Depression in Patients With Diabetes in the Primary Care Setting

Sample Size Determination for Multilevel Hierarchical Designs Using Generalized Linear Mixed Models

Efferent-induced alterations in distortion and reflection otoacoustic emissions in children

Meta-Analysis of Rare Binary Adverse Event Data

Methodology for Good Machine Learning with Multi‐Omics Data

Fat Phobias Held by High School Students in Mexico and Thailand

Likelihood-Based Random-Effect Meta-Analysis of Binary Events

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