| FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC EC Nakajima, N Drezner, X Li, PS Mishra-Kalyani, Y Liu, H Zhao, Y Bi, ... Clinical Cancer Research 28 (8), 1482-1486, 2022 | 199 | 2022 |
| Acute exacerbation and decline in forced vital capacity are associated with increased mortality in idiopathic pulmonary fibrosis MO Paterniti, Y Bi, D Rekić, Y Wang, BA Karimi-Shah, BA Chowdhury Annals of the American Thoracic Society 14 (9), 1395-1402, 2017 | 155 | 2017 |
| FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer Clinical Cancer Research, 2018 | 107 | 2018 |
| FDA approval summary: capmatinib and tepotinib for the treatment of metastatic NSCLC harboring MET exon 14 skipping mutations or alterations LN Mathieu, E Larkins, O Akinboro, P Roy, AK Amatya, MH Fiero, ... Clinical Cancer Research 28 (2), 249-254, 2022 | 85 | 2022 |
| FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions J Kim, D Bradford, E Larkins, LH Pai-Scherf, S Chatterjee, ... Clinical Cancer Research 27 (20), 5452-5456, 2021 | 73 | 2021 |
| FDA Approval summary: Pembrolizumab, atezolizumab, and cemiplimab-rwlc as single agents for first-line treatment of Advanced/Metastatic PD-L1–high NSCLC O Akinboro, E Larkins, LH Pai-Scherf, LN Mathieu, Y Ren, J Cheng, ... Clinical Cancer Research 28 (11), 2221-2228, 2022 | 56 | 2022 |
| A whole-body physiologically based pharmacokinetic model of gefitinib in mice and scale-up to humans Y Bi, J Deng, DJ Murry, G An The AAPS journal 18, 228-238, 2016 | 50 | 2016 |
| Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective Y Bi, J Liu, B Furmanski, H Zhao, J Yu, C Osgood, A Ward, P Keegan, ... Annals of Oncology 30 (4), 644-651, 2019 | 46 | 2019 |
| FDA approval summary: nivolumab in combination with ipilimumab for the treatment of unresectable malignant pleural mesothelioma EC Nakajima, PJ Vellanki, E Larkins, S Chatterjee, PS Mishra-Kalyani, ... Clinical Cancer Research 28 (3), 446-451, 2022 | 38 | 2022 |
| Role of model‐informed drug development in pediatric drug development, regulatory evaluation, and labeling Y Bi, J Liu, L Li, J Yu, A Bhattaram, M Bewernitz, R Li, C Liu, J Earp, L Ma, ... The Journal of Clinical Pharmacology 59, S104-S111, 2019 | 37 | 2019 |
| Model-informed drug development approach supporting approval of adalimumab (HUMIRA) in adolescent patients with hidradenitis suppurativa: a regulatory perspective Y Bi, J Liu, J Wang, RE Epps, D Kettl, K Marcus, S Seo, H Zhu, Y Wang The AAPS Journal 21, 1-6, 2019 | 37 | 2019 |
| FDA approval summary: cabozantinib for differentiated thyroid cancer ES Duke, AK Barone, S Chatterjee, PS Mishra-Kalyani, YL Shen, ... Clinical Cancer Research 28 (19), 4173-4177, 2022 | 25 | 2022 |
| FDA Approval Summary: Mobocertinib for Metastatic Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations ES Duke, L Stapleford, N Drezner, AK Amatya, PS Mishra-Kalyani, ... Clinical Cancer Research 29 (3), 508-512, 2023 | 22 | 2023 |
| Benefit‐risk summary of regorafenib for the treatment of patients with advanced hepatocellular carcinoma that has progressed on sorafenib L Pelosof, S Lemery, S Casak, X Jiang, L Rodriguez, V Pierre, Y Bi, J Liu, ... The Oncologist 23 (4), 496-500, 2018 | 20 | 2018 |
| β-Cyclodextrin enhanced on-line organic solvent field-amplified sample stacking in capillary zone electrophoresis for analysis of ambroxol in human plasma, following liquid … J Li, Y Bi, L Wang, F Sun, Z Chen, G Xu, G Fan Journal of pharmaceutical and biomedical analysis 66, 218-224, 2012 | 19 | 2012 |
| US food and drug administration approval summary: nivolumab plus platinum-doublet chemotherapy for the neoadjuvant treatment of patients with resectable non–small-cell lung cancer O Akinboro, N Drezner, A Amatya, J Runyan, J Fourie-Zirkelbach, M Zhao, ... Journal of Clinical Oncology 41 (17), 3249-3259, 2023 | 16 | 2023 |
| FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors ES Duke, D Bradford, M Marcovitz, AK Amatya, PS Mishra-Kalyani, ... Clinical Cancer Research 29 (18), 3573-3578, 2023 | 15 | 2023 |
| FDA Approval Summary: Dabrafenib in Combination with Trametinib for BRAFV600E Mutation–Positive Low-Grade Glioma MI Barbato, J Nashed, D Bradford, Y Ren, S Khasar, CP Miller, BS Zolnik, ... Clinical Cancer Research 30 (2), 263-268, 2024 | 14 | 2024 |
| Model‐informed drug development in pediatric dose selection Y Bi, J Liu, F Li, J Yu, A Bhattaram, M Bewernitz, R Li, J Ahn, J Earp, L Ma, ... The Journal of Clinical Pharmacology 61, S60-S69, 2021 | 13 | 2021 |
| Model‐informed approach supporting drug development and regulatory evaluation for rare diseases RJ Li, L Ma, F Li, L Li, Y Bi, Y Yuan, Y Li, Y Xu, X Zhang, J Liu, ... The Journal of Clinical Pharmacology 62, S27-S37, 2022 | 10 | 2022 |
