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R Sridhara

Research Profile

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United States Food and Drug Administration

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United States

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TOP 3
Jenny J Zhang; Shenghui Tang; Gideon M Blumenthal; Patricia Cortazar; Kun He; R Sridhara
Overestimation of the effect size in group sequential trials.
Albert Deisseroth; Ann Farrell; Christine Garnett; Joseph Grillo; Edvardas Kaminskas; Hong L Lu; Satjit Brar; Julie Bullock; Laurie B Burke; Wei Chen; Atiqur Rahman; Mark D Rothmann; Haleh Saber; R Sridhara; Jian Wang; Richard Pazdur
U.S. Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high-risk myelofibrosis.
Patricia Cortazar; John Johnson; Robert Justice; Patricia Keegan; R Sridhara; Richard Pazdur
US Food and Drug Administration approval overview in metastatic breast cancer.

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All Publications

2012: Jenny J Zhang; Shenghui Tang; Gideon M Blumenthal; Patricia Cortazar; Kun He; R Sridhara
Overestimation of the effect size in group sequential trials.
Clinical cancer research : an official journal of the American Association for Cancer Research 2012;18(18):4872-6.
2012: Albert Deisseroth; Ann Farrell; Christine Garnett; Joseph Grillo; Edvardas Kaminskas; Hong L Lu; Satjit Brar; Julie Bullock; Laurie B Burke; Wei Chen; Atiqur Rahman; Mark D Rothmann; Haleh Saber; R Sridhara; Jian Wang; Richard Pazdur
U.S. Food and Drug Administration approval: ruxolitinib for the treatment of patients with intermediate and high-risk myelofibrosis.
Clinical cancer research : an official journal of the American Association for Cancer Research 2012;18(12):3212-7.
2012: Patricia Cortazar; John Johnson; Robert Justice; Patricia Keegan; R Sridhara; Richard Pazdur
US Food and Drug Administration approval overview in metastatic breast cancer.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2012;30(14):1705-11.
2012: Martha Donoghue; Joseph E Gootenberg; Kun He; Vaishali Jarral; Josephine M Jee; Patricia Keegan; Lori Kotch; Steven J Lemery; Richard T Lostritto; Anshu Marathe; Anne Pilaro; Stacy Shord; R Sridhara; Ying Wang; Weishi Yuan; Hong Zhao; Liang Zhou; William M Adams; Richard Pazdur
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.
Clinical cancer research : an official journal of the American Association for Cancer Research 2012;18(6):1496-505.
2012: Gideon M Blumenthal; Patricia Cortazar; Robert Justice; Anthony Murgo; R Sridhara; Shenghui Tang; Jenny J Zhang; Richard Pazdur
FDA approval summary: sunitinib for the treatment of progressive well-differentiated locally advanced or metastatic pancreatic neuroendocrine tumors.
The oncologist 2012;17(8):1108-13.
2010: Shakun M Malik; Ke Liu; Xu Qiang; R Sridhara; Shenghui Tang; W David McGuinn; S Leigh Verbois; Anshu Marathe; Gene M Williams; Julie Bullock; Christoffer Tornoe; Sue Ching Lin; Terrance Ocheltree; Milinda Vialpando; Alice Kacuba; Robert Justice; Richard Pazdur
Folotyn (pralatrexate injection) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma: U.S. Food and Drug Administration drug approval summary.
Clinical cancer research : an official journal of the American Association for Cancer Research 2010;16(20):4921-7.
2010: Martin H Cohen; John R Johnson; Somesh Chattopadhyay; Shenghui Tang; Robert Justice; R Sridhara; Richard Pazdur
Approval summary: erlotinib maintenance therapy of advanced/metastatic non-small cell lung cancer (NSCLC).
The oncologist 2010;15(12):1344-51.
2009: Robert C Kane; Ann T Farrell; Rajanikanth Madabushi; Brian Booth; Somesh Chattopadhyay; R Sridhara; Robert Justice; Richard Pazdur
Sorafenib for the treatment of unresectable hepatocellular carcinoma.
The oncologist 2009;14(1):95-100.
2008: Maitreyee Hazarika; Edwin Rock; Gene Williams; Ramzi Dagher; R Sridhara; Brian Booth; Ann Farrell; Robert Justice; Richard Pazdur
Lenalidomide in combination with dexamethasone for the treatment of multiple myeloma after one prior therapy.
The oncologist 2008;13(10):1120-7.
2008: Qin Ryan; Amna Ibrahim; Martin H Cohen; John Johnson; Chia-wen Ko; R Sridhara; Robert Justice; Richard Pazdur
FDA drug approval summary: lapatinib in combination with capecitabine for previously treated metastatic breast cancer that overexpresses HER-2.
The oncologist 2008;13(10):1114-9.
2008: Aloka Chakravarty; R Sridhara
Use of progression-free survival as a surrogate marker in oncology trials: some regulatory issues.
Statistical methods in medical research 2008;17(5):515-8.
2008: Maitreyee Hazarika; Xiaoping Jiang; Qi Liu; Shwu-Luan Lee; Roshni P Ramchandani; Christine Garnett; Micheal S Orr; R Sridhara; Brian Booth; John K Leighton; William Timmer; Ravi Harapanhalli; Ramzi Dagher; Robert Justice; Richard Pazdur
Tasigna for chronic and accelerated phase Philadelphia chromosome--positive chronic myelogenous leukemia resistant to or intolerant of imatinib.
Clinical cancer research : an official journal of the American Association for Cancer Research 2008;14(17):5325-31.
2008: Robert J Lechleider; Edvardas Kaminskas; Xiaoping Jiang; Robeena Aziz; Julie Bullock; Ravindra Kasliwal; Ravi Harapanhalli; Sarah Pope; R Sridhara; John Leighton; Brian Booth; Ramzi Dagher; Robert Justice; Richard Pazdur
Ixabepilone in combination with capecitabine and as monotherapy for treatment of advanced breast cancer refractory to previous chemotherapies.
Clinical cancer research : an official journal of the American Association for Cancer Research 2008;14(14):4378-84.
2008: Michael Brave; Vicki Goodman; Edvardas Kaminskas; Ann Farrell; William Timmer; Sarah Pope; Ravi Harapanhalli; Haleh Saber; David Morse; Julie Bullock; Angela Men; Carol Noory; Roshni P Ramchandani; Leslie Kenna; Brian Booth; Jogarao V S Gobburu; Xiaoping Jiang; R Sridhara; Robert Justice; Richard Pazdur
Sprycel for chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia resistant to or intolerant of imatinib mesylate.
Clinical cancer research : an official journal of the American Association for Cancer Research 2008;14(2):352-9.
2007: Adrian M Senderowicz; John R Johnson; R Sridhara; Paul Zimmerman; Robert Justice; Richard Pazdur
Erlotinib/gemcitabine for first-line treatment of locally advanced or metastatic adenocarcinoma of the pancreas.
Oncology (Williston Park, N.Y.) 2007;21(14):1696-706; discussion 1706-9, 1712, 1715.
2007: Yang-Min Ning; Kun He; Ramzi Dagher; R Sridhara; Ann T Farrell; Robert Justice; Richard Pazdur
Liposomal doxorubicin in combination with bortezomib for relapsed or refractory multiple myeloma.
Oncology (Williston Park, N.Y.) 2007;21(12):1503-8; discussion 1511, 1513, 1516 passim.
2007: Robert C Kane; Ramzi Dagher; Ann Farrell; Chia-Wen Ko; R Sridhara; Robert Justice; Richard Pazdur
Bortezomib for the treatment of mantle cell lymphoma.
Clinical cancer research : an official journal of the American Association for Cancer Research 2007;13(18 Pt 1):5291-4.
2007: Bhupinder S Mann; John R Johnson; Kun He; R Sridhara; Sophia Abraham; Brian P Booth; Leigh Verbois; David E Morse; Josephine M Jee; Sarah Pope; Ravi S Harapanhalli; Ramzi Dagher; Ann Farrell; Robert Justice; Richard Pazdur
Vorinostat for treatment of cutaneous manifestations of advanced primary cutaneous T-cell lymphoma.
Clinical cancer research : an official journal of the American Association for Cancer Research 2007;13(8):2318-22.
2007: Edwin P Rock; Jane A Scott; Dianne L Kennedy; R Sridhara; Richard Pazdur; Laurie B Burke
Challenges to use of health-related quality of life for Food and Drug Administration approval of anticancer products.
Journal of the National Cancer Institute. Monographs 2007;(37):27-30.
2006: Robert C Kane; Ann T Farrell; Haleh Saber; Shenghui Tang; Gene Williams; Josephine M Jee; Chengyi Liang; Brian Booth; Nallaperumal Chidambaram; David Morse; R Sridhara; Patricia Garvey; Robert Justice; Richard Pazdur
Sorafenib for the treatment of advanced renal cell carcinoma.
Clinical cancer research : an official journal of the American Association for Cancer Research 2006;12(24):7271-8.
2006: Michael Brave; Ramzi Dagher; Ann Farrell; Sophia Abraham; Roshni P Ramchandani; Jogarao V S Gobburu; Brian Booth; Xiaoping Jiang; R Sridhara; Robert Justice; Richard Pazdur
Topotecan in combination with cisplatin for the treatment of stage IVB, recurrent, or persistent cervical cancer.
Oncology (Williston Park, N.Y.) 2006;20(11):1401-4, 1410; discussion 1410-11, 1415-6.
2006: Martin H Cohen; John R Johnson; Tristan Massie; R Sridhara; W David McGuinn; Sophia Abraham; Brian P Booth; M Anwar Goheer; David Morse; Xiao H Chen; Nallaperumal Chidambaram; Leslie Kenna; Jogarao V S Gobburu; Robert Justice; Richard Pazdur
Approval summary: nelarabine for the treatment of T-cell lymphoblastic leukemia/lymphoma.
Clinical cancer research : an official journal of the American Association for Cancer Research 2006;12(18):5329-35.
2006: Robert C Kane; Ann T Farrell; R Sridhara; Richard Pazdur
United States Food and Drug Administration approval summary: bortezomib for the treatment of progressive multiple myeloma after one prior therapy.
Clinical cancer research : an official journal of the American Association for Cancer Research 2006;12(10):2955-60.
2005: John R Johnson; Martin Cohen; R Sridhara; Yeh-Fong Chen; Gene M Williams; John Duan; Jogarao V S Gobburu; Brian Booth; Kimberly Benson; John Leighton; Li Shan Hsieh; Nallaperumal Chidambaram; Paul Zimmerman; Richard Pazdur
Approval summary for erlotinib for treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Clinical cancer research : an official journal of the American Association for Cancer Research 2005;11(18):6414-21.
2005: Bhupinder S Mann; John R Johnson; Roswitha Kelly; R Sridhara; Grant Williams; Richard Pazdur
Letrozole in the extended adjuvant treatment of postmenopausal women with history of early-stage breast cancer who have completed 5 years of adjuvant tamoxifen.
Clinical cancer research : an official journal of the American Association for Cancer Research 2005;11(16):5671-7.
2005: Martin H Cohen; John R Johnson; Yeh-Fong Chen; R Sridhara; Richard Pazdur
FDA drug approval summary: erlotinib (Tarceva) tablets.
The oncologist 2005;10(7):461-6.
2005: Martin H Cohen; John R Johnson; Yong-Cheng Wang; R Sridhara; Richard Pazdur
FDA drug approval summary: pemetrexed for injection (Alimta) for the treatment of non-small cell lung cancer.
The oncologist 2005;10(6):363-8.
2005: Edvardas Kaminskas; Ann Farrell; Sophia Abraham; Amy Baird; Li-Shan Hsieh; Shwu-Luan Lee; John K Leighton; Hasmukh Patel; Atiqur Rahman; R Sridhara; Yong-Cheng Wang; Richard Pazdur
Approval summary: azacitidine for treatment of myelodysplastic syndrome subtypes.
Clinical cancer research : an official journal of the American Association for Cancer Research 2005;11(10):3604-8.
2005: Edvardas Kaminskas; Ann T Farrell; Yong-Cheng Wang; R Sridhara; Richard Pazdur
FDA drug approval summary: azacitidine (5-azacytidine, Vidaza) for injectable suspension.
The oncologist 2005;10(3):176-82.
2005: Maitreyee Hazarika; Robert M White; Brian P Booth; Yong-Cheng Wang; Doo Y Lee Ham; Cheng Yi Liang; Atiqur Rahman; Jogarao V S Gobburu; Ning Li; R Sridhara; David E Morse; Richard T Lostritto; Patricia Garvey; John R Johnson; Richard Pazdur
Pemetrexed in malignant pleural mesothelioma.
Clinical cancer research : an official journal of the American Association for Cancer Research 2005;11(3):982-92.
2004: Ramzi Dagher; Ning Li; Sophia Abraham; Atiqur Rahman; R Sridhara; Richard Pazdur
Approval summary: Docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancer.
Clinical cancer research : an official journal of the American Association for Cancer Research 2004;10(24):8147-51.
2004: Martin H Cohen; Grant A Williams; R Sridhara; Gang Chen; W David McGuinn; David Morse; Sophia Abraham; Atiqur Rahman; Chenyi Liang; Richard T Lostritto; Amy Baird; Richard Pazdur
United States Food and Drug Administration Drug Approval summary: Gefitinib (ZD1839; Iressa) tablets.
Clinical cancer research : an official journal of the American Association for Cancer Research 2004;10(4):1212-8.
2004: R Sridhara; Gang Chen; George Y H Chi; Donna J Griebel
Evaluation of health-related quality-of-life measures in oncology drug product applications: issues and concerns.
Journal of biopharmaceutical statistics 2004;14(1):23-30.
2003: Amna Ibrahim; Nancy Scher; Grant Williams; R Sridhara; Ning Li; Gang Chen; John Leighton; Brian Booth; Jogarao V S Gobburu; Atiqur Rahman; Yung Hsieh; Rebecca Wood; Debra Vause; Richard Pazdur
Approval summary for zoledronic acid for treatment of multiple myeloma and cancer bone metastases.
Clinical cancer research : an official journal of the American Association for Cancer Research 2003;9(7):2394-9.
2003: Martin H Cohen; Grant A Williams; R Sridhara; Gang Chen; Richard Pazdur
FDA drug approval summary: gefitinib (ZD1839) (Iressa) tablets.
The oncologist 2003;8(4):303-6.
2001: Peter F Bross; J Beitz; Gang Chen; X H Chen; E Duffy; L Kieffer; S Roy; R Sridhara; Atiqur Rahman; Grant Williams; Richard Pazdur
Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia.
Clinical cancer research : an official journal of the American Association for Cancer Research 2001;7(6):1490-6.
2000: Philip J Cooper; Martha E Chico; Genevieve A Losonsky; Carlos Sandoval; I Espinel; R Sridhara; M Aguilar; Angel Gustavo Guevara; Ronald H Guderian; Myron M Levine; George E Griffin; Thomas B Nutman
Albendazole treatment of children with ascariasis enhances the vibriocidal antibody response to the live attenuated oral cholera vaccine CVD 103-HgR.
The Journal of infectious diseases 2000;182(4):1199-206.
1999: Joseph A Sparano; James Speyer; William J Gradishar; Leonard Liebes; R Sridhara; S Mendoza; David Fry; Merrill J Egorin
Phase I trial of escalating doses of paclitaxel plus doxorubicin and dexrazoxane in patients with advanced breast cancer.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 1999;17(3):880-6.
1998: R Sridhara; Mario A Eisenberger; Victoria Sinibaldi; L M Reyno; Merrill J Egorin
Evaluation of biomarkers of survival response in hormone-refractory prostate cancer patients treated with suramin.
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 1998;7(7):631-4.
1998: Clarence Sarkodee-Adoo; J M Kendall; R Sridhara; Edward J Lee; Charles Alan Schiffer
The relationship between the duration of platelet storage and the development of transfusion reactions.
Transfusion 1998;38(3):229-35.
1998: Merrill J Egorin; DM Rosen; R Sridhara; Lyle Sensenbrenner; Michele Cottler-Fox
Plasma concentrations and pharmacokinetics of dimethylsulfoxide and its metabolites in patients undergoing peripheral-blood stem-cell transplants.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 1998;16(2):610-5.
1997: R Sridhara
Re: prediction of carboplatin clearance from standard morphological and biological patient characteristics.
Journal of the National Cancer Institute 1997;89(20):1546-7.
1997: BA Conley; Merrill J Egorin; R Sridhara; R Finley; Ramzi K Hemady; Suhlan Wu; Nancy Tait; David A Van Echo
Phase I clinical trial of all-trans-retinoic acid with correlation of its pharmacokinetics and pharmacodynamics.
Cancer chemotherapy and pharmacology 1997;39(4):291-9.
1995: R Sridhara; Mario A Eisenberger; Victoria Sinibaldi; L M Reyno; Merrill J Egorin
Evaluation of prostate-specific antigen as a surrogate marker for response of hormone-refractory prostate cancer to suramin therapy.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 1995;13(12):2944-53.
1995: L M Reyno; Merrill J Egorin; Mario A Eisenberger; Victoria Sinibaldi; Eleanor G Zuhowski; R Sridhara
Development and validation of a pharmacokinetically based fixed dosing scheme for suramin.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 1995;13(9):2187-95.
1995: Mario A Eisenberger; Victoria Sinibaldi; L M Reyno; R Sridhara; D I Jodrell; Eleanor G Zuhowski; Katherine Tkaczuk; Mark H Lowitt; Ramzi K Hemady; Stephen C Jacobs
Phase I and clinical evaluation of a pharmacologically guided regimen of suramin in patients with hormone-refractory prostate cancer.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 1995;13(9):2174-86.
1995: E R Broun; R Sridhara; G W Sledge; D Loesch; P H Kneebone; M Hanna; R Hromas; K Cornetta; L H Einhorn
Tandem autotransplantation for the treatment of metastatic breast cancer.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 1995;13(8):2050-5.
1995: L Austin Doyle; Douglas Ross; R Sridhara; A T Fojo; S H Kaufmann; Edward J Lee; Charles Alan Schiffer
Expression of a 95 kDa membrane protein is associated with low daunorubicin accumulation in leukaemic blast cells.
British journal of cancer 1995;71(1):52-8.
1994: Merrill J Egorin; L M Reyno; R M Canetta; D I Jodrell; kenneth d swenerton; J L Pater; J N Burroughs; M J Novak; R Sridhara
Modeling toxicity and response in carboplatin-based combination chemotherapy.
Seminars in oncology 1994;21(5 Suppl 12):7-19.
1994: Douglas Ross; P J Wooten; Y Tong; B Cornblatt; C Levy; R Sridhara; Edward J Lee; Charles Alan Schiffer
Synergistic reversal of multidrug-resistance phenotype in acute myeloid leukemia cells by cyclosporin A and cremophor EL.
Blood 1994;83(5):1337-47.
1994: D I Jodrell; L M Reyno; R Sridhara; Mario A Eisenberger; Katherine Tkaczuk; Eleanor G Zuhowski; Victoria Sinibaldi; M J Novak; Merrill J Egorin
Suramin: development of a population pharmacokinetic model and its use with intermittent short infusions to control plasma drug concentration in patients with prostate cancer.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 1994;12(1):166-75.
1994: Chandra P Belani; Anne Belcher; R Sridhara; Stephen C Schimpff
Instruction in the techniques and concept of supportive care in oncology.
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 1994;2(1):50-5.
1993: Douglas Ross; P J Wooten; R Sridhara; J V Ordóñez; Edward J Lee; Charles Alan Schiffer
Enhancement of daunorubicin accumulation, retention, and cytotoxicity by verapamil or cyclosporin A in blast cells from patients with previously untreated acute myeloid leukemia.
Blood 1993;82(4):1288-99.
1993: J S Abrams; Julie L Eiseman; T J Melink; R Sridhara; D J Hiponia; M M Bell; Chandra P Belani; W H Adler; Joseph Aisner
Immunomodulation of interleukin-2 by cyclophosphamide: a phase IB trial.
Journal of immunotherapy with emphasis on tumor immunology : official journal of the Society for Biological Therapy 1993;14(1):56-64.
1993: L M Reyno; Merrill J Egorin; R M Canetta; D I Jodrell; kenneth d swenerton; J L Pater; J N Burroughs; M J Novak; R Sridhara
Impact of cyclophosphamide on relationships between carboplatin exposure and response or toxicity when used in the treatment of advanced ovarian cancer.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology 1993;11(6):1156-64.
1993: Mario A Eisenberger; L M Reyno; D I Jodrell; Victoria Sinibaldi; Katherine Tkaczuk; R Sridhara; Eleanor G Zuhowski; Mark H Lowitt; Stephen C Jacobs; Merrill J Egorin
Suramin, an active drug for prostate cancer: interim observations in a phase I trial.
Journal of the National Cancer Institute 1993;85(8):611-21.