U.S. Food and Drug Administration Approval: Carfilzomib for the Treatment of Multiple Myeloma
HERNDON, Thomas M, DEISSEROTH, Albert, PALMBY, Todd R, JEE, Josephine, ADAMS, William, MAHAYNI, Houda, BROWN, Janice, DORANTES, Angelica, SRIDHARA, Rajeshwari, FARRELL, Ann T, PAZDUR, Richard, KAMINSKAS, Edvardas, KANE, Robert C, KOTI, Kallappa M, ROTHMANN, Mark D, HABTEMARIAM, Bahru, BULLOCK, Julie, BRAY, Jeffrey D, HAWES, Jessica
Published in Clinical cancer research (01.09.2013)
Published in Clinical cancer research (01.09.2013)
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Journal Article
Issues in Using Progression-Free Survival When Evaluating Oncology Products
FLEMING, Thomas R, ROTHMANN, Mark D, LU, Hong Laura
Published in Journal of clinical oncology (10.06.2009)
Published in Journal of clinical oncology (10.06.2009)
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Journal Article
U.S. Food and Drug Administration Approval Summary: Brentuximab Vedotin for the Treatment of Relapsed Hodgkin Lymphoma or Relapsed Systemic Anaplastic Large-Cell Lymphoma
DE CLARO, R. Angelo, MCGINN, Karen, ROTHMANN, Mark, SHAPIRO, Marjorie, BORREGO, Francisco, CLOUSE, Kathleen, XIAO HONG CHEN, BROWN, Janice, AKINSANYA, Lara, KANE, Robert, KAMINSKAS, Edvardas, FARRELL, Ann, KWITKOWSKI, Virginia, PAZDUR, Richard, BULLOCK, Julie, KHANDELWAL, Aakanksha, HABTEMARIAM, Bahru, OUYANG, Yanli, SABER, Haleh, LEE, Kyung, KOTI, Kallappa
Published in Clinical cancer research (01.11.2012)
Published in Clinical cancer research (01.11.2012)
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Journal Article
U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis
DEISSEROTH, Albert, KAMINSKAS, Edvardas, BULLOCK, Julie, BURKE, Laurie B, RAHMAN, Atiqur, SRIDHARA, Rajeshwari, FARRELL, Ann, PAZDUR, Richard, GRILLO, Joseph, WEI CHEN, SABER, Haleh, LU, Hong L, ROTHMANN, Mark D, BRAR, Satjit, JIAN WANG, GARNETT, Christine
Published in Clinical cancer research (15.06.2012)
Published in Clinical cancer research (15.06.2012)
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Journal Article
U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia
Alvandi, Firoozeh, Kwitkowski, Virginia E., Ko, Chia‐Wen, Rothmann, Mark D., Ricci, Stacey, Saber, Haleh, Ghosh, Debasis, Brown, Janice, Pfeiler, Erika, Chikhale, Elsbeth, Grillo, Joseph, Bullock, Julie, Kane, Robert, Kaminskas, Edvardas, Farrell, Ann T., Pazdur, Richard
Published in The oncologist (Dayton, Ohio) (01.01.2014)
Published in The oncologist (Dayton, Ohio) (01.01.2014)
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Journal Article
U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab
LEMERY, Steven J, ZHANG, Jenny, KEEGAN, Patricia, PAZDUR, Richard, ROTHMANN, Mark D, JUN YANG, EARP, Justin, HONG ZHAO, MCDOUGAL, Andrew, PILARO, Anne, CHIANG, Raymond, GOOTENBERG, Joseph E
Published in Clinical cancer research (01.09.2010)
Published in Clinical cancer research (01.09.2010)
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Journal Article
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation
Fleming, Thomas R., Garnett, Christine E., Conklin, Laurie S., Corriol-Rohou, Solange, Hariharan, Sudharshan, Hsu, Daphne, Mueller-Velten, Guenther, Mulugeta, Yeruk, Portman, Ronald, Rothmann, Mark D., Stockbridge, Norman L., Wandel, Simon, Zhang, Jialu, Yao, Lynne
Published in Therapeutic innovation & regulatory science (01.01.2023)
Published in Therapeutic innovation & regulatory science (01.01.2023)
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Journal Article
Some essential considerations in the design and conduct of non-inferiority trials
Fleming, Thomas R, Odem-Davis, Katherine, Rothmann, Mark D, Li Shen, Yuan
Published in Clinical trials (London, England) (01.08.2011)
Published in Clinical trials (London, England) (01.08.2011)
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Journal Article
Approval Summary for Imatinib Mesylate Capsules in the Treatment of Chronic Myelogenous Leukemia
COHEN, Martin H, WILLIAMS, Grant, ROTHMANN, Mark, GANG CHEN, KHIN MAUNG U, STATEN, Ann M, PAZDUR, Richard, JOHNSON, John R, DUAN, John, GOBBURU, Jogarao, RAHMAN, Atiqur, BENSON, Kimberly, LEIGHTON, John, KIM, Sung K, WOOD, Rebecca
Published in Clinical cancer research (01.05.2002)
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Published in Clinical cancer research (01.05.2002)
Journal Article
U.S. Food and Drug Administration Approval: Panitumumab for Epidermal Growth Factor Receptor–Expressing Metastatic Colorectal Carcinoma with Progression Following Fluoropyrimidine-, Oxaliplatin-, and Irinotecan-Containing Chemotherapy Regimens
GIUSTI, Ruthann M, SHASTRI, Kaushikkumar, KEEGAN, Patricia, WEISS, Karen D, PAZDUR, Richard, PILARO, Anne M, FUCHS, Chana, CORDOBA-RODRIGUEZ, Ruth, KOTI, Kallappa, ROTHMANN, Mark, MEN, Angela Yuxin, HONG ZHAO, HUGHES, Monica
Published in Clinical cancer research (01.03.2008)
Published in Clinical cancer research (01.03.2008)
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Journal Article
Design and analysis of non-inferiority mortality trials in oncology
Rothmann, Mark, Li, Ning, Chen, Gang, Chi, George Y. H., Temple, Robert, Tsou, Hsiao-Hui
Published in Statistics in medicine (30.01.2003)
Published in Statistics in medicine (30.01.2003)
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Journal Article
Perspectives on informative Bayesian methods in pediatrics
Travis, James, Rothmann, Mark, Thomson, Andrew
Published in Journal of biopharmaceutical statistics (02.11.2023)
Published in Journal of biopharmaceutical statistics (02.11.2023)
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Journal Article
Missing Data in Biologic Oncology Products
Rothmann, Mark D., Koti, Kallappa, Lee, Kyung Yul, Lu, Hong Laura, Shen, Yuan Li
Published in Journal of biopharmaceutical statistics (01.11.2009)
Published in Journal of biopharmaceutical statistics (01.11.2009)
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Journal Article
14th Annual University of Pennsylvania Conference on statistical issues in clinical trials/subgroup analysis in clinical trials: Opportunities and challenges (afternoon panel discussion)
Imai, Kosuke, Rosenblum, Michael, Rothmann, Mark
Published in Clinical trials (London, England) (01.08.2023)
Published in Clinical trials (London, England) (01.08.2023)
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Journal Article
On Non-inferiority Analysis Based On Delta-method Confidence Intervals
Rothmann, Mark D., Tsou, Hsiao-Hui
Published in Journal of biopharmaceutical statistics (01.08.2003)
Published in Journal of biopharmaceutical statistics (01.08.2003)
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Journal Article
Testing in a Prespecified Subgroup and the Intent-to-Treat Population
Rothmann, Mark D., Zhang, Jenny J., Lu, Laura, Fleming, Thomas R.
Published in Drug information journal (01.03.2012)
Published in Drug information journal (01.03.2012)
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Journal Article
Bayesian Hierarchical Models for Subgroup Analysis
Wang, Yun, Tu, Wenda, Koh, William, Travis, James, Abugov, Robert, Hamilton, Kiya, Zheng, Mengjie, Crackel, Roberto, Bonangelino, Pablo, Rothmann, Mark
Published in Pharmaceutical statistics : the journal of the pharmaceutical industry (15.07.2024)
Published in Pharmaceutical statistics : the journal of the pharmaceutical industry (15.07.2024)
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Journal Article