Zobrazeno 1 - 10
of 11
pro vyhledávání: '"Leigh Verbois"'
Autor:
Patrick H. Lukulay, R. Duane Satzger, Ja Cinta S. Batson, Nicola Ranieri, Daniel Bempong, Leigh Verbois
Publikováno v:
Malaria Journal
Background The US FDA recently developed CD3+, a counterfeit detection tool that is based on sample illumination at specific wavelengths of light and visual comparison of suspect sample and packaging materials to an authentic sample. To test performa
Autor:
Wendy Wilson, Amna Ibrahim, Anthony J. Murgo, Brenda Gehrke, Suchitra Balakrishnan, Katherine Thornton, Shenghui Tang, Richard Pazdur, Anshu Marathe, Geoffrey Kim, Pengfei Song, Debasis Ghosh, Christine Garnett, Robert Justice, V. Ellen Maher, Brian Booth, John Duan, Young Jin Moon, Leigh Verbois, Qi Liu, Robert Dorsam, Lisa Skarupa, Somesh Chattopadhyay, Sarah Pope Miksinski, Hao Zhu, Haripada Sarker
Publikováno v:
Clinical Cancer Research. 18:3722-3730
On April 6, 2011, the U.S. Food and Drug Administration approved vandetanib (Caprelsa tablets; AstraZeneca Pharmaceuticals LP) for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable, locally advanced, o
Autor:
Robert J. Parker, R. Daniel Mellon, S. Leigh Verbois, Donna A. Volpe, Aspandiar G. Katki, Thomas Colatsky, Timothy J. Kropp, Grainne A. McMahon Tobin
Publikováno v:
Regulatory Toxicology and Pharmacology. 59:385-390
The safe disposal of unused opioid drugs is an area of regulatory concern. While toilet flushing is recommended for some drugs to prevent accidental exposure, there is a need for data that can support a more consistent disposal policy based on an ass
Autor:
Robert Justice, Shakun M. Malik, Richard Pazdur, Rajeshwari Sridhara, Alice Kacuba, Julie Bullock, Terrance Ocheltree, Ke Liu, Gene M. Williams, Milinda Vialpando, Anshu Marathe, Shenghui Tang, S. Leigh Verbois, W. David McGuinn, Xu Qiang, Sue Ching Lin, Christoffer W. Tornøe
Publikováno v:
Clinical Cancer Research. 16:4921-4927
Purpose: On September 24, 2009, the U.S. Food and Drug Administration granted accelerated approval for Folotyn (pralatrexate injection, Allos Therapeutics, Inc.) as a single agent for the treatment of patients with relapsed or refractory peripheral T
Autor:
Timothy Kropp, S. Leigh Verbois, W. David McGuinn, Hans Rosenfeldt, M. Stacey Ricci, Kimberly Benson
Publikováno v:
Toxicology and Applied Pharmacology. 243:125-133
The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in A
Autor:
Jogarao V. S. Gobburu, Edwin P. Rock, Cheng Yi Liang, Sophia Abraham, Nallaperumal Chidambaram, S. Leigh Verbois, David E. Morse, Janet X. Jiang, Shenghui Tang, Richard Pazdur, Robert Justice, Roshni Ramchandani, Vicki L. Goodman, Ramzi Dagher, Brian Booth, Kooros Mahjoob
Publikováno v:
Clinical Cancer Research. 13:1367-1373
Purpose: To describe the Food and Drug Administration (FDA) review and approval of sunitinib malate (Sutent). Sunitinib received regular approval for the treatment of gastrointestinal stromal tumor (GIST) after disease progression or intolerance to i
Autor:
Patricia Tabernero, Leigh Verbois, James E. Herrington, Mark R. Witkowski, Michael D. Green, Eric Sampson, R. Duane Satzger, Khamxay Thao, Chindaphone Phonlavong, Nicola Ranieri, Paul N. Newton
Publikováno v:
The American Journal of Tropical Medicine and Hygiene
There is an urgent need for accurate and inexpensive handheld instruments for the evaluation of medicine quality in the field. A blinded evaluation of the diagnostic accuracy of the Counterfeit Detection Device 3 (CD-3), developed by the US Food and
Autor:
Sophia Abraham, Robert C. Kane, Lilliam A. Rosario, Grant R. Williams, Kimberly Benson, David E. Morse, Yong-Cheng Wang, Richard Pazdur, Sean Bradley, Cheng Yi Liang, Atiqur Rahman, Anwar Goheer, Shwu-Luan Lee, John K. Leighton, Richard T. Lostritto, Jogarao V. S. Gobburu, S. Leigh Verbois, Ann T. Farrell, William D. McGuinn, Peter F. Bross, Margaret E. Brower
Publikováno v:
Clinical Cancer Research. 10:3954-3964
Purpose: Multiple myeloma is a malignant plasma cell disorder accounting for about 10% of hematological malignancies. Despite treatment advances, including hematopoietic stem-cell transplantation to facilitate administration of high-dose cytotoxic ch
Autor:
Leigh Verbois, Ann T. Farrell, Robert Justice, Rajeshwari Sridhara, Bhupinder S. Mann, John R. Johnson, Sophia Abraham, David E. Morse, Richard Pazdur, Brian Booth, Josephine M. Jee, Sarah Pope, Kun He, Ravi Harapanhalli, Ramzi Dagher
Publikováno v:
Clinical cancer research : an official journal of the American Association for Cancer Research. 13(8)
Purpose: To discuss vorinostat approval for treatment of cutaneous manifestations of advanced cutaneous T-cell lymphoma (CTCL). Experimental Design: Data from 1 single-arm, open-label, multicenter pivotal trial and 11 other trials submitted to suppor
Autor:
S. Leigh Verbois, Kooros Mahjoob, David L. Morse, Janet X. Jiang, Vicki L. Goodman, Ramzi Dagher, Richard Pazdur, Robert Justice, Edwin P. Rock
Publikováno v:
The oncologist. 12(1)
On January 26, 2006, sunitinib (Sutent) received regular approval as monotherapy for the treatment of patients with gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate (Gleevec). Time-to-tumor progression (