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Volumn 4, Issue 2, 2006, Pages 76-79

Bone quality: A perspective from the Food and Drug Administration

Author keywords

[No Author keywords available]

Indexed keywords

CALCIUM; ETIDRONIC ACID; FLUORIDE SODIUM; VITAMIN D;

EID: 33750338870     PISSN: 15441873     EISSN: 15442241     Source Type: Journal    
DOI: 10.1007/s11914-006-0006-5     Document Type: Review
Times cited : (10)

References (9)
  • 1
    • 0035857351 scopus 로고    scopus 로고
    • Osteoporosis prevention, diagnosis, and therapy
    • NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy: [review]
    • NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy: Osteoporosis prevention, diagnosis, and therapy [review]. JAMA 2001, 285:785-795.
    • (2001) JAMA , vol.285 , pp. 785-795
  • 2
    • 0034694856 scopus 로고    scopus 로고
    • Ethical principles for medical research involving human subjects
    • World Medical Association Declaration of Helsinki
    • World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 2000, 284:3043-3045.
    • (2000) JAMA , vol.284 , pp. 3043-3045
  • 3
    • 0142027573 scopus 로고    scopus 로고
    • Osteoporosis panel summary
    • Capron A, Donaldson S, Raisz LG, Swift S: Osteoporosis panel summary. J Bone Miner Res 2003, 18:1160-1162. This article summarizes a collection of articles in the Journal of Bone and Mineral Research that encapsulates the presentations and discussions from the June, 2002, National Institutes of Health conference on study design and ethical considerations for osteoporosis drug development trials.
    • (2003) J Bone Miner Res , vol.18 , pp. 1160-1162
    • Capron, A.1    Donaldson, S.2    Raisz, L.G.3    Swift, S.4
  • 4
    • 84868380065 scopus 로고    scopus 로고
    • US Food and Drug Administration, Center for Drug Evaluation and Research. Silver Spring, MD, September 25. Accessed January 21, 2006
    • US Food and Drug Administration, Center for Drug Evaluation and Research: Endocrinologic and Metabolic Drugs Advisory Committee meeting documents. Silver Spring, MD, September 25, 2002. http://www.fda.gov/ohrms/dockets/ac/cder02. htm#EndocrinologicMetabolicDrugs. Accessed January 21, 2006.
    • (2002) Endocrinologic and Metabolic Drugs Advisory Committee Meeting Documents
  • 5
    • 0003077113 scopus 로고
    • A regulatory authority's opinion about surrogate endpoints
    • Edited by Nimmo WS and Tucker GT. New York: John Wiley & Sons
    • Temple RJ: A regulatory authority's opinion about surrogate endpoints. In Clinical Measurement in Drug Evaluation. Edited by Nimmo WS and Tucker GT. New York: John Wiley & Sons; 1995:3-22. This chapter provides an overview of surrogate endpoints in the drug approval process. It focuses mainly on endpoints related to cardiovascular outcomes.
    • (1995) Clinical Measurement in Drug Evaluation , pp. 3-22
    • Temple, R.J.1
  • 6
    • 0142091171 scopus 로고    scopus 로고
    • The Food and Drug Administration's osteoporosis guidance document: Past, present, and future
    • Colman EG: The Food And Drug Administration's osteoporosis guidance document: past, present, and future. J Bone Miner Res 2003, 18:1125-1128. This article provides a comprehensive history of the FDA's guidelines for preclinical and clinical evaluation of agents used in the prevention or treatment of osteoporosis.
    • (2003) J Bone Miner Res , vol.18 , pp. 1125-1128
    • Colman, E.G.1
  • 7
    • 0025374223 scopus 로고
    • Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis
    • Riggs BL, Hodgon SF, O'Fallon WM, et al.: Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis. N Engl J Med 1990, 322:802-809.
    • (1990) N Engl J Med , vol.322 , pp. 802-809
    • Riggs, B.L.1    Hodgon, S.F.2    O'Fallon, W.M.3
  • 8
    • 0027738472 scopus 로고
    • Four-year study of intermittent cyclic etidronate treatment of postmenopausal osteoporosis: Three years of blinded therapy followed by one year of open therapy
    • Harris ST, Watts NB, Jackson RD, et al.: Four-year study of intermittent cyclic etidronate treatment of postmenopausal osteoporosis: three years of blinded therapy followed by one year of open therapy. Am J Med 1993, 95:557-567.
    • (1993) Am J Med , vol.95 , pp. 557-567
    • Harris, S.T.1    Watts, N.B.2    Jackson, R.D.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.