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U.S. Food and Drug Administration Approval: Carfilzomib for the Treatment of Multiple Myeloma

Clinical cancer research, 2013-09, Vol.19 (17), p.4559-4563

2013

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Issues in Using Progression-Free Survival When Evaluating Oncology Products

Journal of clinical oncology, 2009-06, Vol.27 (17), p.2874-2880

2009

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U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia

The oncologist (Dayton, Ohio), 2014-01, Vol.19 (1), p.94-99

2014

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Finding the (biomarker-defined) subgroup of patients who benefit from a novel therapy: No time for a game of hide and seek

Clinical trials (London, England), 2023-08, Vol.20 (4), p.341-350

2023

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U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis

Clinical cancer research, 2012-06, Vol.18 (12), p.3212-3217

2012

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U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab

Clinical cancer research, 2010-09, Vol.16 (17), p.4331-4338

2010

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Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation

Therapeutic innovation & regulatory science, 2023-01, Vol.57 (1), p.109-120

2023

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Inferences on a life distribution by sampling from the ages or the ages at death

Lifetime data analysis, 2006-09, Vol.12 (3), p.305-323

Rothmann, Mark D

2006

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Missing Data in Biologic Oncology Products

Journal of biopharmaceutical statistics, 2009-11, Vol.19 (6), p.1074-1084

2009

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Approval summary: Imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors

Clinical cancer research, 2002-10, Vol.8 (10), p.3034-3038

2002

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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

Clinical cancer research, 2008-03, Vol.14 (5), p.1296-1302

2008

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Comparison of the transcriptome in circulating leukocytes in early lactation between primiparous and multiparous cows provides evidence for age-related changes

BMC genomics, 2021-09, Vol.22 (1), p.693-693, Article 693

2021

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The FDA and The Lancet: an exchange

The Lancet (British edition), 2001-08, Vol.358 (9279), p.415-415

2001

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The FDA and The Lancet: an exchange

The Lancet (British edition), 2001-08, Vol.358 (9279), p.415-415

2001

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U.S. Food and Drug Administration Approval: Carfilzomib for the Treatment of Multiple Myeloma

Issues in Using Progression-Free Survival When Evaluating Oncology Products

U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia

Finding the (biomarker-defined) subgroup of patients who benefit from a novel therapy: No time for a game of hide and seek

U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis

U.S. Food and Drug Administration Approval: Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab

Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation

Inferences on a life distribution by sampling from the ages or the ages at death

Missing Data in Biologic Oncology Products

Approval summary: Imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors

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

Comparison of the transcriptome in circulating leukocytes in early lactation between primiparous and multiparous cows provides evidence for age-related changes

The FDA and The Lancet: an exchange

The FDA and The Lancet: an exchange

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