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Volumn 5, Issue 4, 2010, Pages 553-556

Editorial: The FDA's perspective on the risk for rapid rise in hemoglobin in treating CKD anemia: Quo vadis

Author keywords

[No Author keywords available]

Indexed keywords

ANTIANEMIC AGENT; HEMOGLOBIN; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN;

EID: 77950961681     PISSN: 15559041     EISSN: 1555905X     Source Type: Journal    
DOI: 10.2215/CJN.00490110     Document Type: Editorial
Times cited : (16)

References (27)
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  • 6
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    • Medical officer clinical review: Darbepoetin alfa (Aranesp) for the treatment of anemia associated with chronic renal failure, Rockville, MD, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, 2001. Available at: http://www.fda.gov/ downloads/Drugs/ DevelopmentApprovalProcess/HowDrugsareDeveloped andApproved/ApprovalApplications/Therapeutic BiologicApplications/ucm086019.pdf. Accessed January 17, 2009
    • (2001) Medical Officer Clinical Review: Darbepoetin Alfa (Aranesp) for the Treatment of Anemia Associated with Chronic Renal Failure
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    • FDA Briefing Document May 4, Oncologic Drugs Advisory Committee. Accessed January 17, 2010
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    • (2004)
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    • (2010)
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    • Procrit label/Epogen label. Available at: http://www.accessdata.fda.gov/ drugsatfda-docs/label/2007/103234s5122lbl.pdf. Accessed January 17, 2009
    • (2009)
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    • FDA Advisory Committee Briefing Document Joint Meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Committee: Reassessment of the Risks of Erythropoiesis-Stimulating Agents (ESAs) Administered for the Treatment of Anemia Associated with Chronic Renal Failure, Rockville, MD, Food and Drug Administration, Accessed January 17, 2010
    • FDA Advisory Committee Briefing Document Joint Meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Committee: Reassessment of the Risks of Erythropoiesis-Stimulating Agents (ESAs) Administered for the Treatment of Anemia Associated with Chronic Renal Failure, Rockville, MD, Food and Drug Administration, 2007. Available at: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4315b1-01-FDA.pdf. Accessed January 17, 2010
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.