| FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines … G Kim, G Ison, AE McKee, H Zhang, S Tang, T Gwise, R Sridhara, E Lee, ... Clinical cancer research 21 (19), 4257-4261, 2015 | 571 | 2015 |
| Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review P Zhao, L Zhang, JA Grillo, Q Liu, JM Bullock, YJ Moon, P Song, SS Brar, ... Clinical Pharmacology & Therapeutics 89 (2), 259-267, 2011 | 547 | 2011 |
| FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer L Amiri-Kordestani, GM Blumenthal, QC Xu, L Zhang, SW Tang, L Ha, ... Clinical cancer research 20 (17), 4436-4441, 2014 | 347 | 2014 |
| FDA approval: palbociclib for the treatment of postmenopausal patients with estrogen receptor–positive, HER2-negative metastatic breast cancer JA Beaver, L Amiri-Kordestani, R Charlab, W Chen, T Palmby, A Tilley, ... Clinical Cancer Research 21 (21), 4760-4766, 2015 | 333 | 2015 |
| FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAFV600E Mutation G Kim, AE McKee, YM Ning, M Hazarika, M Theoret, JR Johnson, QC Xu, ... Clinical Cancer Research 20 (19), 4994-5000, 2014 | 231 | 2014 |
| FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase–positive non–small cell lung cancer S Khozin, GM Blumenthal, L Zhang, S Tang, M Brower, E Fox, W Helms, ... Clinical cancer research 21 (11), 2436-2439, 2015 | 209 | 2015 |
| Effect of the cathepsin K inhibitor odanacatib on bone resorption biomarkers in healthy postmenopausal women: two double‐blind, randomized, placebo‐controlled phase I studies SA Stoch, S Zajic, J Stone, DL Miller, K Van Dyck, MJ Gutierrez, ... Clinical Pharmacology & Therapeutics 86 (2), 175-182, 2009 | 199 | 2009 |
| Model‐informed drug development: current US regulatory practice and future considerations Y Wang, H Zhu, R Madabushi, Q Liu, SM Huang, I Zineh Clinical Pharmacology & Therapeutics 105 (4), 899-911, 2019 | 179 | 2019 |
| Radium Ra 223 dichloride injection: US Food and Drug Administration drug approval summary PG Kluetz, W Pierce, VE Maher, H Zhang, S Tang, P Song, Q Liu, ... Clinical cancer research 20 (1), 9-14, 2014 | 172 | 2014 |
| 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 | 172 | 2012 |
| Tasigna for chronic and accelerated phase Philadelphia chromosome–positive chronic myelogenous leukemia resistant to or intolerant of imatinib M Hazarika, X Jiang, Q Liu, SL Lee, R Ramchandani, C Garnett, MS Orr, ... Clinical Cancer Research 14 (17), 5325-5331, 2008 | 172 | 2008 |
| Bone density, strength, and formation in adult cathepsin K (−/−) mice B Pennypacker, M Shea, Q Liu, P Masarachia, P Saftig, S Rodan, ... Bone 44 (2), 199-207, 2009 | 168 | 2009 |
| 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 | 165 | 2014 |
| Association of time‐varying clearance of nivolumab with disease dynamics and its implications on exposure response analysis C Liu, J Yu, H Li, J Liu, Y Xu, P Song, Q Liu, H Zhao, J Xu, VE Maher, ... Clinical Pharmacology & Therapeutics 101 (5), 657-666, 2017 | 161 | 2017 |
| FDA approval summary: Atezolizumab for the treatment of patients with progressive advanced urothelial carcinoma after platinum‐containing chemotherapy YM Ning, D Suzman, VE Maher, L Zhang, S Tang, T Ricks, T Palmby, ... The oncologist 22 (6), 743-749, 2017 | 160 | 2017 |
| FDA approval of palbociclib in combination with fulvestrant for the treatment of hormone receptor–positive, HER2-negative metastatic breast cancer AJ Walker, S Wedam, L Amiri-Kordestani, E Bloomquist, S Tang, ... Clinical Cancer Research 22 (20), 4968-4972, 2016 | 150 | 2016 |
| First FDA approval of dual anti-HER2 regimen: pertuzumab in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer GM Blumenthal, NS Scher, P Cortazar, S Chattopadhyay, S Tang, P Song, ... Clinical cancer research 19 (18), 4911-4916, 2013 | 138 | 2013 |
| FDA approval: ribociclib for the treatment of postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer A Shah, E Bloomquist, S Tang, W Fu, Y Bi, Q Liu, J Yu, P Zhao, ... Clinical Cancer Research 24 (13), 2999-3004, 2018 | 107 | 2018 |
| US food and drug administration approval: neratinib for the extended adjuvant treatment of early-stage HER2-positive breast cancer H Singh, AJ Walker, L Amiri-Kordestani, J Cheng, S Tang, P Balcazar, ... Clinical Cancer Research 24 (15), 3486-3491, 2018 | 99 | 2018 |
| Odanacatib, a selective cathepsin K inhibitor to treat osteoporosis: safety, tolerability, pharmacokinetics and pharmacodynamics–results from single oral dose studies in … SA Stoch, S Zajic, JA Stone, DL Miller, L Van Bortel, KC Lasseter, ... British journal of clinical pharmacology 75 (5), 1240-1254, 2013 | 96 | 2013 |
Rajnikanth MadabushiFDA在 fda.has.gov 的电子邮件经过验证
Rajnikanth MadabushiFDA在 fda.has.gov 的电子邮件经过验证