-
2
-
-
33748452038
-
Levothyroxine dosage and the limitations of current bioequivalence standards
-
Hennessey JV 2006 Levothyroxine dosage and the limitations of current bioequivalence standards. Nat Clin Pract Endocrinol Metab 2:474-475.
-
(2006)
Nat Clin Pract Endocrinol Metab
, vol.2
, pp. 474-475
-
-
Hennessey, J.V.1
-
3
-
-
0036072916
-
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
-
4
-
-
1842429851
-
Are bioequivalence studies of levothyroxine sodium formulations in euthyroid volunteers reliable?
-
Blakesley VA, Awni W, Locke C, Ludden TM, 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.A.1
Awni, W.2
Locke, C.3
Ludden, T.M.4
Granneman, G.R.5
Braverman, L.E.6
-
5
-
-
0346102452
-
Evaluation of the therapeutic efficacy of different levothyroxine preparations in the treatment of human thyroid disease
-
Klein I, Danzi S 2003 Evaluation of the therapeutic efficacy of different levothyroxine preparations in the treatment of human thyroid disease. Thyroid 13:1127-1132.
-
(2003)
Thyroid
, vol.13
, pp. 1127-1132
-
-
Klein, I.1
Danzi, S.2
-
8
-
-
3542991444
-
-
American Thyroid Association, The Endocrine Society, and American Association of Clinical Endocrinologists 2004 Joint Statement on the U.S. Food and Drug Administration's Decision Regarding Bioequivalence of Levothyroxine Sodium. Thyroid 14:486.
-
American Thyroid Association, The Endocrine Society, and American Association of Clinical Endocrinologists 2004 Joint Statement on the U.S. Food and Drug Administration's Decision Regarding Bioequivalence of Levothyroxine Sodium. Thyroid 14:486.
-
-
-
-
9
-
-
27644542257
-
-
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.
-
-
-
-
10
-
-
27644545773
-
-
Bolton S 2005 Bioequivalence studies for levothyroxine. AAPS J 7:E47-E53.
-
Bolton S 2005 Bioequivalence studies for levothyroxine. AAPS J 7:E47-E53.
-
-
-
-
12
-
-
27644507081
-
-
Green WL 2005 New questions regarding bioequivalence of levothyroxine preparations: a clinician's response. AAPS J 7:E54-E58.
-
Green WL 2005 New questions regarding bioequivalence of levothyroxine preparations: a clinician's response. AAPS J 7:E54-E58.
-
-
-
-
13
-
-
0037365469
-
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
-
14
-
-
59649126768
-
-
Food and Drug Administration 2003 Advisory Committee for Pharmaceutical Science, Record of Proceedings. Available at: http://www.fda.gov/ohrms/dockets/ ac/03/transcripts/3926T2.pdf. Accessed on: January 8, 2006.
-
Food and Drug Administration 2003 Advisory Committee for Pharmaceutical Science, Record of Proceedings. Available at: http://www.fda.gov/ohrms/dockets/ ac/03/transcripts/3926T2.pdf. Accessed on: January 8, 2006.
-
-
-
-
15
-
-
33846130066
-
L-T4 bioequivalence and hormone replacement studies via feedback control simulations
-
Eisenberg M, Samuels M, DiStefano JJ, 3rd 2006 L-T4 bioequivalence and hormone replacement studies via feedback control simulations. Thyroid 16:1279-1292.
-
(2006)
Thyroid
, vol.16
, pp. 1279-1292
-
-
Eisenberg, M.1
Samuels, M.2
DiStefano 3rd, J.J.3
-
16
-
-
59649110372
-
-
Food and Drug Administration 2005 Public Meeting for Levothyroxine Sodium Therapeutic Equivalence. May 23, 2005, Washington, DC. Available at: http://www.fda.gov/cder/meeting/levothyroxine2005.htm. Accessed on: January 2008.
-
Food and Drug Administration 2005 Public Meeting for Levothyroxine Sodium Therapeutic Equivalence. May 23, 2005, Washington, DC. Available at: http://www.fda.gov/cder/meeting/levothyroxine2005.htm. Accessed on: January 2008.
-
-
-
-
17
-
-
59649086251
-
-
Food and Drug Administration 2006 Advisory Committee for Pharmaceutical Science, Record of Proceedings. Available at: http://www.fda.gov/ohrms/dockets/ ac/cder06.html#PharmScience. Accessed on: April 26, 2007.
-
Food and Drug Administration 2006 Advisory Committee for Pharmaceutical Science, Record of Proceedings. Available at: http://www.fda.gov/ohrms/dockets/ ac/cder06.html#PharmScience. Accessed on: April 26, 2007.
-
-
-
-
18
-
-
0013069775
-
-
U.S. Department of Heath and Human Services, Food and Drug Administration, Available at:, Accessed on: January 2008
-
U.S. Department of Heath and Human Services, Food and Drug Administration 1997 Federal Register 62 FR 43535. Available at: http://www.fda.gov/cder/ fedreg/fr14au97-83.htm. Accessed on: January 2008.
-
(1997)
Federal Register
, vol.62
, Issue.FR
, pp. 43535
-
-
-
19
-
-
59649127725
-
-
Duffy EP; Food and Drug Administration 2006 Stability of levothyroxine sodium products - Presentation made to the FDA on October 4, 2006. Available at: www.fda.gov/ohrms/dockets/AC/06/slides/2006-4228S1-01-04-Eric%20Duffy%20slides. pdf. Accessed on: April 26, 2007.
-
Duffy EP; Food and Drug Administration 2006 Stability of levothyroxine sodium products - Presentation made to the FDA on October 4, 2006. Available at: www.fda.gov/ohrms/dockets/AC/06/slides/2006-4228S1-01-04-Eric%20Duffy%20slides. pdf. Accessed on: April 26, 2007.
-
-
-
-
20
-
-
0142028204
-
The effect of excipients on the stability of levothyroxine sodium pentahydrate tablets
-
Patel H, Stalcup A, Dansereau R, Sakr A 2003 The effect of excipients on the stability of levothyroxine sodium pentahydrate tablets. Int J Pharm 264:35-43.
-
(2003)
Int J Pharm
, vol.264
, pp. 35-43
-
-
Patel, H.1
Stalcup, A.2
Dansereau, R.3
Sakr, A.4
-
21
-
-
59649118746
-
Available at: http://www.fda.gov/bbs/topics/ ENFORCE/2001/ENF00703.html. Accessed on
-
U.S. Department of Heath and Human Services, January
-
U.S. Department of Heath and Human Services, Food and Drug Administration 2001 FDA Enforcement Report. Available at: http://www.fda.gov/bbs/topics/ ENFORCE/2001/ENF00703.html. Accessed on: January 2008.
-
(2008)
Food and Drug Administration 2001 FDA Enforcement Report
-
-
-
22
-
-
59649126051
-
Available at: http://www.fda.gov/bbs/topics/ enforce/2005/ENF00899.html. Accessed on
-
U.S. Department of Heath and Human Services, January
-
U.S. Department of Heath and Human Services, Food and Drug Administration 2005 FDA Enforcement Report. Available at: http://www.fda.gov/bbs/topics/ enforce/2005/ENF00899.html. Accessed on: January 2008.
-
(2008)
Food and Drug Administration 2005 FDA Enforcement Report
-
-
-
23
-
-
59649109022
-
Available at: http://www.fda.gov/bbs/topics/ enforce/2006/ENF00969.html. Accessed on
-
U.S. Department of Heath and Human Services, January
-
U.S. Department of Heath and Human Services, Food and Drug Administration 2006 FDA Enforcement Report. Available at: http://www.fda.gov/bbs/topics/ enforce/2006/ENF00969.html. Accessed on: January 2008.
-
(2008)
Food and Drug Administration 2006 FDA Enforcement Report
-
-
-
24
-
-
59649084044
-
Available at: http://www.fda.gov/bbs/topics/ enforce/2007/ENF00993.html. Accessed on
-
U.S. Department of Heath and Human Services, January
-
U.S. Department of Heath and Human Services, Food and Drug Administration 2007 FDA Enforcement Report. Available at: http://www.fda.gov/bbs/topics/ enforce/2007/ENF00993.html. Accessed on: January 2008.
-
(2008)
Food and Drug Administration 2007 FDA Enforcement Report
-
-
-
25
-
-
59649086735
-
-
U.S. Department of Heath and Human Services, Food and Drug Administration 2007 FDA News: FDA acts to ensure thyroid drugs don't lose potency before expiration date. Available at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01717. html. Accessed on: January 2008.
-
U.S. Department of Heath and Human Services, Food and Drug Administration 2007 FDA News: FDA acts to ensure thyroid drugs don't lose potency before expiration date. Available at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01717. html. Accessed on: January 2008.
-
-
-
-
26
-
-
53649090210
-
-
Eisenberg M, Samuels M, Distefano JJ 2008 Extensions, validation & clinical applications of a feedback control system simulator of the hypothalamo-pituitary-thyroid axis. Thyroid: Accepted. (In press.)
-
Eisenberg M, Samuels M, Distefano JJ 2008 Extensions, validation & clinical applications of a feedback control system simulator of the hypothalamo-pituitary-thyroid axis. Thyroid: Accepted. (In press.)
-
-
-
-
27
-
-
24344495292
-
The evidence for a narrower thyrotropin reference range is compelling
-
Wartofsky L, Dickey RA 2005 The evidence for a narrower thyrotropin reference range is compelling. J Clin Endocrinol Metab 90:5483-5488.
-
(2005)
J Clin Endocrinol Metab
, vol.90
, pp. 5483-5488
-
-
Wartofsky, L.1
Dickey, R.A.2
-
29
-
-
59649100927
-
Personal communication by e-mail. April 9
-
April 26
-
Hennessey JV, Sherman S. Personal communication by e-mail. April 9, 2007-April 26, 2007.
-
(2007)
, pp. 2007
-
-
Hennessey, J.V.1
Sherman, S.2
-
30
-
-
0028951298
-
Multiphasic thyrotropin responses to thyroid hormone administration in man
-
Spencer CA, LoPresti JS, Nicoloff JT, Dlott R, Schwarzbein D 1995 Multiphasic thyrotropin responses to thyroid hormone administration in man. J Clin Endocrinol Metab 80:854-859.
-
(1995)
J Clin Endocrinol Metab
, vol.80
, pp. 854-859
-
-
Spencer, C.A.1
LoPresti, J.S.2
Nicoloff, J.T.3
Dlott, R.4
Schwarzbein, D.5
-
31
-
-
0023867084
-
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
-
Oxf
-
Carr D, McLeod DT, Parry G, Thornes HM 1988 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. Clin Endocrinol (Oxf ) 28:325-333.
-
(1988)
Clin Endocrinol
, vol.28
, pp. 325-333
-
-
Carr, D.1
McLeod, D.T.2
Parry, G.3
Thornes, H.M.4
-
32
-
-
0021366473
-
High-performance liquid chromatographic assay for sodium levothyroxine in tablet formulations: Content uniformity applications
-
Garnick RL, Burt GF, Long DA, Bastian JW, Aldred JP 1984 High-performance liquid chromatographic assay for sodium levothyroxine in tablet formulations: content uniformity applications. J Pharm Sci 73:75-77.
-
(1984)
J Pharm Sci
, vol.73
, pp. 75-77
-
-
Garnick, R.L.1
Burt, G.F.2
Long, D.A.3
Bastian, J.W.4
Aldred, J.P.5
-
33
-
-
0034997482
-
Identification and quantitation of sodium-thyroxine and its degradation products by LC using electrochemical and MS detection
-
Kazemifard AG, Moore DE, Aghazadeh A 2001 Identification and quantitation of sodium-thyroxine and its degradation products by LC using electrochemical and MS detection. J Pharm Biomed Anal 25:697-711.
-
(2001)
J Pharm Biomed Anal
, vol.25
, pp. 697-711
-
-
Kazemifard, A.G.1
Moore, D.E.2
Aghazadeh, A.3
-
34
-
-
0015899526
-
Serum triiodothyronine in health and disease
-
Oxf
-
Patel YC, Burger HG 1973 Serum triiodothyronine in health and disease. Clin Endocrinol (Oxf ) 2:339-349.
-
(1973)
Clin Endocrinol
, vol.2
, pp. 339-349
-
-
Patel, Y.C.1
Burger, H.G.2
-
35
-
-
0015733833
-
Serum triiodothyronine, thyroxine and thyroid-stimulating hormone in endemic goiter: A comparison of goitrous and nongoitrous subjects in New Guinea
-
Patel YC, Pharoah PO, Hornabrook RW, Hetzel BS 1973 Serum triiodothyronine, thyroxine and thyroid-stimulating hormone in endemic goiter: a comparison of goitrous and nongoitrous subjects in New Guinea. J Clin Endocrinol Metab 37:783-789.
-
(1973)
J Clin Endocrinol Metab
, vol.37
, pp. 783-789
-
-
Patel, Y.C.1
Pharoah, P.O.2
Hornabrook, R.W.3
Hetzel, B.S.4
-
36
-
-
0026502953
-
Kinetics of degradation of levothyroxine in aqueous solution and in solid state
-
Won CM 1992 Kinetics of degradation of levothyroxine in aqueous solution and in solid state. Pharm Res 9:131-137.
-
(1992)
Pharm Res
, vol.9
, pp. 131-137
-
-
Won, C.M.1
|