Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008 JY Lee, CE Garnett, JVS Gobburu, VA Bhattaram, S Brar, JC Earp, ... Clinical pharmacokinetics 50, 627-635, 2011 | 190 | 2011 |
Vandetanib for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease: US Food and Drug … K Thornton, G Kim, VE Maher, S Chattopadhyay, S Tang, YJ Moon, ... Clinical Cancer Research 18 (14), 3722-3730, 2012 | 184 | 2012 |
US Food and Drug Administration approval: crizotinib for treatment of advanced or metastatic non–small cell lung cancer that is anaplastic lymphoma kinase positive SM Malik, VE Maher, KE Bijwaard, RL Becker, L Zhang, SW Tang, P Song, ... Clinical cancer research 20 (8), 2029-2034, 2014 | 168 | 2014 |
FDA approval: uridine triacetate for the treatment of patients following fluorouracil or capecitabine overdose or exhibiting early-onset severe toxicities following … G Ison, JA Beaver, WD McGuinn Jr, TR Palmby, J Dinin, R Charlab, ... Clinical Cancer Research 22 (18), 4545-4549, 2016 | 98 | 2016 |
Integrated cellular bone homeostasis model for denosumab pharmacodynamics in multiple myeloma patients A Marathe, MC Peterson, DE Mager Journal of Pharmacology and Experimental Therapeutics 326 (2), 555-562, 2008 | 85 | 2008 |
FDA approval summary: Lenvatinib for progressive, radio-iodine–refractory differentiated thyroid cancer A Nair, SJ Lemery, J Yang, A Marathe, L Zhao, H Zhao, X Jiang, K He, ... Clinical Cancer Research 21 (23), 5205-5208, 2015 | 82 | 2015 |
Eribulin mesylate for the treatment of patients with refractory metastatic breast cancer: use of a “physician's choice” control arm in a randomized approval trial M Donoghue, SJ Lemery, W Yuan, K He, R Sridhara, S Shord, H Zhao, ... Clinical Cancer Research 18 (6), 1496-1505, 2012 | 65 | 2012 |
Folotyn (pralatrexate injection) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma: US Food and Drug Administration drug approval summary SM Malik, K Liu, X Qiang, R Sridhara, S Tang, WD McGuinn Jr, ... Clinical Cancer Research 16 (20), 4921-4927, 2010 | 59 | 2010 |
Integrated model for denosumab and ibandronate pharmacodynamics in postmenopausal women DD Marathe, A Marathe, DE Mager Biopharmaceutics & drug disposition 32 (8), 471-481, 2011 | 43 | 2011 |
Numerical validation and properties of a rapid binding approximation of a target-mediated drug disposition pharmacokinetic model A Marathe, W Krzyzanski, DE Mager Journal of pharmacokinetics and pharmacodynamics 36, 199-219, 2009 | 25 | 2009 |
Quantitative relationship between AUEC of absolute neutrophil count and duration of severe neutropenia for G‐CSF in breast cancer patients L Li, L Ma, SJ Schrieber, NA Rahman, A Deisseroth, AT Farrell, Y Wang, ... Clinical Pharmacology & Therapeutics 104 (4), 742-748, 2018 | 20 | 2018 |
Dosage considerations for canakinumab in children with periodic fever syndromes L Zhuang, J Chen, J Yu, A Marathe, C Sahajwalla, M Borigini, J Maynard, ... Clinical Pharmacology & Therapeutics 106 (3), 557-567, 2019 | 17 | 2019 |
Canagliflozin use in patients with renal impairment—Utility of quantitative clinical pharmacology analyses in dose optimization M Khurana, J Vaidyanathan, A Marathe, N Mehrotra, CG Sahajwalla, ... The Journal of Clinical Pharmacology 55 (6), 647-656, 2015 | 11 | 2015 |
Response similarity assessment between polyarticular juvenile idiopathic arthritis and adult rheumatoid arthritis for biologics R Singh, VD Ivaturi, J Penzenstadler, T Liu, J Chen, A Marathe, P Ji, ... Clinical Pharmacology & Therapeutics 110 (1), 98-107, 2021 | 10 | 2021 |
A disease progression model of longitudinal lung function decline in idiopathic pulmonary fibrosis patients Y Bi, D Rekić, MO Paterniti, J Chen, A Marathe, BA Chowdhury, ... Journal of pharmacokinetics and pharmacodynamics 48, 55-67, 2021 | 8 | 2021 |
Application of Bayesian statistics to support approval of intravenous belimumab in children with systemic lupus erythematosus in the United States G Pottackal, J Travis, R Neuner, R Rothwell, G Levin, L Nie, J Niu, ... ARTHRITIS & RHEUMATOLOGY 71, 2019 | 7 | 2019 |
Pharmacometric Bridging Approach for US Food and Drug Administration Approval and Identification of Topiramate Dosing Regimen for Pediatric Patients 2-9 Years of Age With Epilepsy A Marathe, C Liu, LP Kapcala, N Hershkowitz, A Men, R Uppoor, M Mehta, ... Journal of Pharmaceutical Sciences 108 (4), 1598-1603, 2019 | 6 | 2019 |
Impact of dose selection on parameter estimation using a rapid binding approximation model of target-mediated drug disposition A Marathe, S Van Wart, DE Mager Journal of pharmacokinetics and pharmacodynamics 38, 223-235, 2011 | 5 | 2011 |
A novel pharmacokinetic bridging strategy to support a change in the route of administration for biologics P Ji, N Nikolov, S Seymour, R Glaser, Y Ren, L Li, A Marathe, Y Ren, ... Journal of Pharmaceutical Sciences 108 (7), 2490-2499, 2019 | 4 | 2019 |
New advancements in exposure-response analysis to inform regulatory decision making L Zhao, L Hongshan, A Marathe, J Yu, D Rekić, N Mehrotra, V Sinha, ... Pharmacokinetics in Drug Development: Problems and Challenges in Oncology …, 2016 | 3 | 2016 |