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Thyroid
Volumn 18, Issue 5, 2008, Pages 487-490
The FDA revises requirements for levothyroxine products
Author keywords

[No Author keywords available]
Indexed keywords

LEVOTHYROXINE; THYROTROPIN;
EID: 43449101192     PISSN: 10507256     EISSN: None     Source Type: Journal    
DOI: 10.1089/thy.2008.0109     Document Type: Note
Times cited : (10)
References (13)
  • 1
    • 43449127629 scopus 로고    scopus 로고
    • Accessed on March 24, 2008
    • http://www.fda.gov/cder/drug/infopage/levothyroxine/qa.htm. Accessed on March 24, 2008.
  • 2
    • 43449122294 scopus 로고    scopus 로고
    • Accessed on March 25, 2008
    • http://www.fda.gov/ohrms/dockets/ac/06/minutes/2006-4228m1.pdf. Accessed on March 25, 2008.
  • 3
    • 33748452038 scopus 로고    scopus 로고
    • Levothyroxine bioequivalence: Are the guidelines flawed? Nat Clin Pract
    • Hennessey JV 2006 Levothyroxine bioequivalence: are the guidelines flawed? Nat Clin Pract Endocrinol Metab 2:474-475.
    • (2006) Endocrinol Metab , vol.2 , pp. 474-475
    • Hennessey, J.V.1
  • 4
    • 43449124825 scopus 로고    scopus 로고
    • Accessed on March 24, 2008
    • http://www.fda.gov/cder/guidance/4964dft.pdf. Accessed on March 24, 2008.
  • 5
    • 0036072916 scopus 로고    scopus 로고
    • Levothyroxine: Therapeutic use and regulatory issues related to bioequivalence
    • Wartofsky L 2002 Levothyroxine: therapeutic use and regulatory issues related to bioequivalence. Expert Opin Pharmacother 3:727-732.
    • (2002) Expert Opin Pharmacother , vol.3 , pp. 727-732
    • Wartofsky, L.1
  • 6
    • 0037365469 scopus 로고    scopus 로고
    • Levothyroxine a new drug? Since when? How could that be?
    • Hennessey JV 2003 Levothyroxine a new drug? Since when? How could that be? Thyroid 13:279-282.
    • (2003) Thyroid , vol.13 , pp. 279-282
    • Hennessey, J.V.1
  • 7
    • 1842429851 scopus 로고    scopus 로고
    • Are bioequivalence studies of levothyroxine sodium formulations in euthyroid volunteers reliable?
    • Blakesley V, Awni W, Locke C, Ludden T, Granneman GR, Braverman LE 2004 Are bioequivalence studies of levothyroxine sodium formulations in euthyroid volunteers reliable? Thyroid 14:191-200.
    • (2004) Thyroid , vol.14 , pp. 191-200
    • Blakesley, V.1    Awni, W.2    Locke, C.3    Ludden, T.4    Granneman, G.R.5    Braverman, L.E.6
  • 8
    • 27644542257 scopus 로고    scopus 로고
    • Blakesley VA 2005 Current methodology to assess bioequivalence of levothyroxine sodium products is inadequate. AAPS J 7:E42-E46.
    • Blakesley VA 2005 Current methodology to assess bioequivalence of levothyroxine sodium products is inadequate. AAPS J 7:E42-E46.
  • 9
    • 27744554848 scopus 로고    scopus 로고
    • Generic levothyroxine: What is all the fuss about?
    • Garber JR, Hennessey JV 2005 Generic levothyroxine: what is all the fuss about? Endocr Pract 11:205-207.
    • (2005) Endocr Pract , vol.11 , pp. 205-207
    • Garber, J.R.1    Hennessey, J.V.2
  • 10
    • 43449094804 scopus 로고    scopus 로고
    • Accessed on March 24, 2008
    • http://www.thyroid.org/professionals/advocacy/04_05_26_fda.html. Accessed on March 24, 2008.
  • 11
    • 43449104844 scopus 로고    scopus 로고
    • Accessed on March 24, 2008
    • http://www.thyroid.org/professionals/education/bioequivalence.html. Accessed on March 24, 2008.
  • 12
    • 43449136018 scopus 로고    scopus 로고
    • Accessed on March 24, 2008
    • http://www.aace.com/newsroom/press/2006/index.php?r=20061003. Accessed on March 24, 2008.
  • 13
    • 43449127904 scopus 로고    scopus 로고
    • Accessed on March 24, 2008
    • http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4228S1-index.htm. Accessed on March 24, 2008.

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.