Search Results - "Dagher, Ramzi"

Bortezomib for the Treatment of Mantle Cell Lymphoma by KANE, Robert C, DAGHER, Ramzi, FARRELL, Ann, KO, Chia-Wen, SRIDHARA, Rajeshwari, JUSTICE, Robert, PAZDUR, Richard

“…Purpose: To describe the Food and Drug Administration review and marketing approval considerations for bortezomib (Velcade) for the treatment of patients with…”
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Approval Summary: Sunitinib for the Treatment of Imatinib Refractory or Intolerant Gastrointestinal Stromal Tumors and Advanced Renal Cell Carcinoma by GOODMAN, Vicki L, ROCK, Edwin P, CHIDAMBARAM, Nallaperumal, JIANG, Janet X, SHENGHUI TANG, MAHJOOB, Kooros, JUSTICE, Robert, PAZDUR, Richard, DAGHER, Ramzi, RAMCHANDANI, Roshni P, ABRAHAM, Sophia, GOBBURU, Jogarao V. S, BOOTH, Brian P, VERBOIS, S. Leigh, MORSE, David E, CHENG YI LIANG

“…Purpose: To describe the Food and Drug Administration (FDA) review and approval of sunitinib malate (Sutent). Sunitinib received regular approval for the…”
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Food and Drug Administration Drug Approval Summary: Sunitinib Malate for the Treatment of Gastrointestinal Stromal Tumor and Advanced Renal Cell Carcinoma by Rock, Edwin P., Goodman, Vicki, Jiang, Janet X., Mahjoob, Kooros, Verbois, S. Leigh, Morse, David, Dagher, Ramzi, Justice, Robert, Pazdur, Richard

“…Learning Objectives After completing this course, the reader will be able to: Discuss the mechanism of action of the newly approved targeted cancer drug…”
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Vorinostat for Treatment of Cutaneous Manifestations of Advanced Primary Cutaneous T-Cell Lymphoma by MANN, Bhupinder S, JOHNSON, John R, HARAPANHALLI, Ravi S, DAGHER, Ramzi, FARRELL, Ann, JUSTICE, Robert, PAZDUR, Richard, KUN HE, SRIDHARA, Rajeshwari, ABRAHAM, Sophia, BOOTH, Brian P, VERBOIS, Leigh, MORSE, David E, JEE, Josephine M, POPE, Sarah

“…Purpose: To discuss vorinostat approval for treatment of cutaneous manifestations of advanced cutaneous T-cell lymphoma (CTCL). Experimental Design: Data from…”
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Tasigna for Chronic and Accelerated Phase Philadelphia Chromosome–Positive Chronic Myelogenous Leukemia Resistant to or Intolerant of Imatinib by HAZARIKA, Maitreyee, XIAOPING JIANG, TIMMER, William, HARAPANHALLI, Ravi, DAGHER, Ramzi, JUSTICE, Robert, PAZDUR, Richard, QI LIU, LEE, Shwu-Luan, RAMCHANDANI, Roshni, GARNETT, Christine, ORR, Micheal S, SRIDHARA, Rajeshwari, BOOTH, Brian, LEIGHTON, John K

“…Purpose: This Food and Drug Administration (FDA) approval report describes the data and analyses leading to the approval by the FDA of nilotinib (Tasigna,…”
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Rhabdomyosarcoma: An Overview by Dagher, Ramzi, Helman, Lee

“…Rhabdomyosarcoma (RMS) is a malignant tumor of mesenchymal origin thought to arise from cells committed to a skeletal muscle lineage. With approximately 250…”
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Ixabepilone in Combination with Capecitabine and as Monotherapy for Treatment of Advanced Breast Cancer Refractory to Previous Chemotherapies by Lechleider, Robert J, Kaminskas, Edvardas, Jiang, Xiaoping, Aziz, Robeena, Bullock, Julie, Kasliwal, Ravindra, Harapanhalli, Ravi, Pope, Sarah, Sridhara, Rajeshwari, Leighton, John, Booth, Brian, Dagher, Ramzi, Justice, Robert, Pazdur, Richard

“…Purpose: To describe the considerations leading to marketing approval of ixabepilone in combination with capecitabine and as monotherapy for the treatment of…”
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Dexrazoxane (Totect™): FDA Review and Approval for the Treatment of Accidental Extravasation Following Intravenous Anthracycline Chemotherapy by Kane, Robert C., McGuinn, W. David, Dagher, Ramzi, Justice, Robert, Pazdur, Richard

“…Learning Objectives After completing this course, the reader will be able to: Evaluate anthracycline tissue injury resulting from drug extravasation…”
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Population Pharmacokinetic-Based Dosing of Intravenous Busulfan in Pediatric Patients by Booth, Brian P., Rahman, Atiqur, Dagher, Ramzi, Griebel, Donna, Lennon, Shari, Fuller, David, Sahajwalla, Chandra, Mehta, Mehul, Gobburu, Jogarao V. S.

“…The objective of this study was to characterize the pharmacokinetics (PK) of intravenous busulfan in pediatric patients and provide dosing recommendations…”
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Randomized Trial and Pharmacokinetic Study of Pegfilgrastim versus Filgrastim after Dose-Intensive Chemotherapy in Young Adults and Children with Sarcomas by FOX, Elizabeth, WIDEMANN, Brigitte C, STEINBERG, Seth M, BALIS, Frank M, HAWKINS, Douglas S, JAYAPRAKASH, Nalini, DAGHER, Ramzi, AIKIN, Alberta A, BERNSTEIN, Donna, LONG, Lauren, MACKALL, Crystal, HELMAN, Lee

“…Purpose: To compare the effectiveness, tolerance, and pharmacokinetics of a single dose of pegfilgrastim to daily filgrastim in children and young adults with…”
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Approval summary: Docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancer by DAGHER, Ramzi, NING LI, ABRAHAM, Sophia, RAHMAN, Atiqur, SRIDHARA, Raji, PAZDUR, Richard

“…Docetaxel, a taxane previously approved for the treatment of breast cancer and non-small cell lung cancer, was approved by the United States Food and Drug…”
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Good Clinical Practice and the Conduct of Clinical Studies in Pediatric Oncology by Devine, Susan, CCRP, Dagher, Ramzi N., MD, Weiss, Karen D., MD, Santana, Victor M., MD

“…This article discusses the principles that guide good clinical practice standards, with particular emphasis on how they to relate to pediatric oncology…”
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Approval Summary by Dagher, Ramzi, Li, Ning, Abraham, Sophia, Rahman, Atiqur, Sridhara, Raji, Pazdur, Richard

“…Purpose: Docetaxel, a taxane previously approved for the treatment of breast cancer and non–small cell lung cancer, was approved by the United States Food and…”
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Abstract IA12: Regulatory Considerations in Addressing Resistance Mechanisms by Dagher, Ramzi N.

“…Abstract There is no specific regulatory definition of drug resistance. However, regulatory considerations relevant to strategies designed to address drug…”
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Pediatric Oncology: Regulatory Initiatives by Hirschfeld, Steven, Shapiro, Alla, Dagher, Ramzi, Pazdur, Richard

“…The majority of children with cancer receive therapy as participants in clinical research protocols coordinated by national pediatric cooperative groups. One…”
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A Sponsor’s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan by Wolter, Kevin D., Kamatani, Asayuki, Suzuki, Yumiko, Imaeda, Takayuki, Dagher, Ramzi, Safferman, Allan, Junor, Rod

“…Background Following marketing authorization in Japan, for almost all new drugs or new indications, postmarketing studies (PMS) are a regulatory requirement…”
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Approval summary: Imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors by DAGHER, Ramzi, COHEN, Martin, PAZDUR, Richard, WILLIAMS, Gene, ROTHMANN, Mark, GOBBURU, Jogarao, ROBBIE, Gabriel, RAHMAN, Atiqur, GANG CHEN, STATEN, Ann, GRIEBEL, Donna

“…Imatinib mesylate (Gleevec; Novartis, East Hanover, NJ)is a receptor tyrosine kinase inhibitor approved previously in 2001 by the United States Food and Drug…”
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Lenalidomide in Combination with Dexamethasone for the Treatment of Multiple Myeloma After One Prior Therapy by Hazarika, Maitreyee, Rock, Edwin, Williams, Gene, Dagher, Ramzi, Sridhara, Rajeshwari, Booth, Brian, Farrell, Ann, Justice, Robert, Pazdur, Richard

“…Purpose. Lenalidomide (CC‐5013, Revlimid®; Celgene Corporation, Summit, NJ), a thalidomide analogue, was granted approval by the U.S. Food and Drug…”
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Accelerated Approval of Oncology Products: A Decade of Experience by Dagher, Ramzi, Johnson, John, Williams, Grant, Keegan, Patricia, Pazdur, Richard

“…We review the regulatory history of the accelerated approval process and summarize the U.S. Food and Drug Administration experience with accelerated approvals…”
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Liposomal doxorubicin in combination with bortezomib for relapsed or refractory multiple myeloma by Ning, Yang-Min, He, Kun, Dagher, Ramzi, Sridhara, Rajeshwari, Farrell, Ann T, Justice, Robert, Pazdur, Richard

“…On May 17, 2007, doxorubicin HCl liposome injection (Doxil) in combination with bortezomib (Velcade) received approval from the US Food and Drug Administration…”
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