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Volumn 7, Issue 1, 2005, Pages

Bioequvalence studies for levothyroxine

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; LEVOTHYROXINE; THYROTROPIN; BIOLOGICAL MARKER; THYROXINE;

EID: 27644545773     PISSN: 15221059     EISSN: 15221059     Source Type: Journal    
DOI: 10.1208/aapsj070106     Document Type: Article
Times cited : (32)

References (13)
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    • Jones Pharma, Inc. March 28
    • Citizen's Petition. Jones Pharma, Inc. March 28, 2003.
    • (2003) Citizen's Petition
  • 3
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    • Abbott Laboratories. August 25
    • Citizen's Petition. Abbott Laboratories. August 25, 2003.
    • (2003) Citizen's Petition
  • 4
    • 1842429851 scopus 로고    scopus 로고
    • Are bioequivalence studies of levothyroxine sodium formulations in euthyroid volunteers reliable?
    • Blakesley V, Awni NV, Locke C, Ludden T, Granneman GR, Braverman LE. Are bioequivalence studies of levothyroxine sodium formulations in euthyroid volunteers reliable? Thyroid. 2004;14:191-200.
    • (2004) Thyroid , vol.14 , pp. 191-200
    • Blakesley, V.1    Awni, N.V.2    Locke, C.3    Ludden, T.4    Granneman, G.R.5    Braverman, L.E.6
  • 5
    • 33646662183 scopus 로고    scopus 로고
    • Food and Drug Administration. FDA Advisory Committee for Pharmaceutical Science Briefing Document From Abbott Laboratories. Rockville, MD; May 12-13, 2003. Available at: Accessed March 23
    • Food and Drug Administration. FDA Advisory Committee for Pharmaceutical Science. Briefing Document From Abbott Laboratories. Rockville, MD; May 12-13, 2003. Available at: http://www.fda.gov/ohrms/dockets/ac/03/briefing/ 3926B1_02_A-Abbot%20.htm. Accessed March 23, 2005.
    • (2005)
  • 6
    • 33646655830 scopus 로고    scopus 로고
    • Levothyroxine Sodium Tablets
    • Mylan Laboratories, Inc. Canonsburg, PA: Mylan Laboratories, Inc
    • Mylan Laboratories, Inc. Levothyroxine Sodium Tablets. Canonsburg, PA: Mylan Laboratories, Inc; 2000:76-187.
    • (2000) , pp. 76-187
  • 7
    • 33646635845 scopus 로고    scopus 로고
    • FDA Advisory Committee for Pharmaceutical Science. Record of Proceedings
    • Food and Drug Administration. March 13, 2003. Available at: PharmaceuticalScience. Accessed March 23
    • Food and Drug Administration. FDA Advisory Committee for Pharmaceutical Science. Record of Proceedings. March 13, 2003. Available at: http://www.fda.gov/ohrms/dockets/ac/cder03.html# PharmaceuticalScience. Accessed March 23, 2005.
    • (2005)
  • 8
    • 33646659989 scopus 로고    scopus 로고
    • Abbott Laboratories. August 25
    • Citizen's Petition. Abbott Laboratories. August 25, 2003.
    • (2003) Citizen's Petition
  • 9
    • 33646661958 scopus 로고    scopus 로고
    • Food and Drug Administration. FDA Response to Abbott Petition, Citizen's Petition #2003P-0126/CP1 Document PDN 1. June 29
    • Food and Drug Administration. FDA Response to Abbott Petition, Citizen's Petition #2003P-0126/CP1, Document PDN 1. June 29, 2004.
    • (2004)
  • 10
    • 0023867084 scopus 로고
    • Fine adjustment of thyroxine replacement dosage: Comparison of the thyrotrophin releasing hormone test using a sensitive thyrotrophin assay with measurement of free thyroid hormones and clinical assessment
    • Carr D, McLeod DT, Parry G, Thornes HM. Fine adjustment of thyroxine replacement dosage: comparison of the thyrotrophin releasing hormone test using a sensitive thyrotrophin assay with measurement of free thyroid hormones and clinical assessment. J Clin Endocrinol. 1988;28:325-333.
    • (1988) J. Clin. Endocrinol. , vol.28 , pp. 325-333
    • Carr, D.1    McLeod, D.T.2    Parry, G.3    Thornes, H.M.4
  • 11
    • 0003577283 scopus 로고    scopus 로고
    • Food and Drug Administration. Title 21. Available at: Accessed: March 23 CFR 320.33
    • Food and Drug Administration. Code of Federal Regulations. Title 21, Volume 5: CFR 320.33. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/ CFRSearch.cfm?fr=320.24. Accessed: March 23, 2005.
    • (2005) Code of Federal Regulations , vol.5
  • 13
    • 33646648562 scopus 로고    scopus 로고
    • Health Canada. Expert Advisory Committee on Bioavailability. Record of Proceedings. April 16, 2003. Available at Accessed March 23
    • Health Canada. Expert Advisory Committee on Bioavailability. Record of Proceedings. April 16, 2003. Available at http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/2003-04-16_e.html. Accessed March 23, 2005.
    • (2005)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.