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Biomarkers and surrogate markers: An FDA perspective [PDF]
NeuroRx, 2004 Interest is increasing rapidly in the use of surrogate markers as primary measures of the effectiveness of investigational drugs in definitive drug trials. Many such surrogate markers have been proposed as potential candidates for use in definitive effectiveness trials of agents to treat neurologic or psychiatric disease, but as of this date, there are
Russell Katz
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Amyotrophic Lateral Sclerosis and Other Motor Neuron Disorders, 2004
(2004). Use of surrogate markers. Amyotrophic Lateral Sclerosis and Other Motor Neuron Disorders: Vol. 5, No. sup1, pp. 103-103.
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(2004). Use of surrogate markers. Amyotrophic Lateral Sclerosis and Other Motor Neuron Disorders: Vol. 5, No. sup1, pp. 103-103.
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Surrogate Markers of Disease in Mastocytosis
International Archives of Allergy and Immunology, 2002Measurement of surrogate mast cell-related products in blood or urine is often performed to assess disease extent in evaluating patients with mastocytosis. Serum tryptase and 24-hour urine histamine metabolites are the most commonly used surrogate markers of mastocytosis.
Cem, Akin, Dean D, Metcalfe
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Surrogate markers for atherosclerotic disease
Current Opinion in Lipidology, 2005Novel treatment modalities for cardiovascular prevention are emerging rapidly. Since it is virtually impossible to evaluate all these new compounds in long-term trials using clinical end points, there is an urgent need for validated surrogate markers of atherosclerosis to save both time and costs.
Sankatsing, RR +8 more
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Mechanisms of immunotherapy and surrogate markers
Allergy: European Journal of Allergy and Clinical Immunology, 2011To cite this article: Till S. Mechanisms of immunotherapy and surrogate markers. Allergy 2011; 66 (Suppl. 95): 25–27.AbstractUnderstanding mechanisms of inducible antigen‐specific tolerance will improve immunotherapy and reveal the most relevant biomarkers for objectively measuring response to immunotherapy in clinical trials and routine practice ...
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Noninvasive surrogate markers of atherosclerosis
The American Journal of Cardiology, 2002Noninvasive imaging techniques offer a unique opportunity to study the relation of surrogate markers to the development of atherosclerosis. These noninvasive imaging modalities include: (1) carotid artery, coronary, and aorta imaging; (2) left ventricular echocardiography imaging; (3) electron-beam computed tomography; (4) magnetic resonance imaging ...
Steven B, Feinstein +2 more
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Surrogate Markers of Angiogenesis and Metastasis
2003Angiogenesis, the formation of new blood vessels from a preexisting vascular network, is a complex multistep process under the control of positive and negative factors (bi1,bi2). Growth, progression, and metastasis of malignant tumors are angiogenesis-dependent processes (3-bi5).
G, Ranieri, G, Gasparini
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The cytogenetic response as a surrogate marker of survival
Seminars in Hematology, 2003In the management of chronic myeloid leukemia (CML), cytogenetic response (CgR) has been recognized as an important prognostic factor and is used in predicting patient outcome. Imatinib (Gleevec) (formerly STI571), a potent inhibitor of BCR-ABL, is very effective in inducing CgRs in chronic-phase CML patients, even in late chronic-phase patients in ...
Gianantonio, Rosti +3 more
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Surrogate Markers of Angiogenesis
2007Anti-angiogenic drugs have entered the anticancer drug arsenal, but there is a clear need to identify patients who are likely to benefit from this therapeutic strategy. Circulating endothelial cells (CECs) and progenitors (CEPs) have been reported to be modulated in cancer patients.
Valentina Raia +2 more
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Annals of Internal Medicine, 1992
Excerpt To the editors:The editorial by Lagakos and Hoth (1) addresses an interesting aspect of clinical trials involving the acquired immunodeficiency syndrome (AIDS).
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Excerpt To the editors:The editorial by Lagakos and Hoth (1) addresses an interesting aspect of clinical trials involving the acquired immunodeficiency syndrome (AIDS).
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