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Volumn 43, Issue 14, 2004, Pages 1037-1053

Assessment of levothyroxine sodium bioavailability: Recommendations for an improved methodology based on the pooled analysis of eight identically designed trials with 396 drug exposures

Author keywords

[No Author keywords available]

Indexed keywords

HENNING; LEVOTHYROXINE SODIUM;

EID: 10044237745     PISSN: 03125963     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003088-200443140-00006     Document Type: Article
Times cited : (21)

References (46)
  • 1
    • 0035954660 scopus 로고    scopus 로고
    • Subclinical hypothyroidism
    • Cooper DS. Subclinical hypothyroidism. N Engl J Med 2001; 345: 260-5
    • (2001) N Engl J Med , vol.345 , pp. 260-265
    • Cooper, D.S.1
  • 2
    • 0028245904 scopus 로고
    • Thyroxine therapy
    • Toft AD. Thyroxine therapy. N Engl J Med 1994; 331: 174-80
    • (1994) N Engl J Med , vol.331 , pp. 174-180
    • Toft, A.D.1
  • 3
    • 0023103073 scopus 로고
    • Replacement dose, metabolism, and bioavailability of levothyroxine in the treatment of hypothyroidism
    • Fish LH, Schwartz HL, Cavanaugh J, et al. Replacement dose, metabolism, and bioavailability of levothyroxine in the treatment of hypothyroidism. N Engl J Med 1987; 316: 764-70
    • (1987) N Engl J Med , vol.316 , pp. 764-770
    • Fish, L.H.1    Schwartz, H.L.2    Cavanaugh, J.3
  • 4
    • 0030788224 scopus 로고    scopus 로고
    • Altered bioavailability due to changes in the formulation of a commercial preparation of levothyroxine in patients with differentiated thyroid carcinoma
    • Olveira G, Almaraz MC, Soriguer F, et al. Altered bioavailability due to changes in the formulation of a commercial preparation of levothyroxine in patients with differentiated thyroid carcinoma. Clin Endocrinol 1997; 46: 707-11
    • (1997) Clin Endocrinol , vol.46 , pp. 707-711
    • Olveira, G.1    Almaraz, M.C.2    Soriguer, F.3
  • 5
    • 0020576992 scopus 로고
    • Equivalence of levothyroxine tablets [letter]
    • Lee M. Equivalence of levothyroxine tablets [letter]. Drug Intell Clin Pharm 1983; 17: 265.
    • (1983) Drug Intell Clin Pharm , vol.17 , pp. 265
    • Lee, M.1
  • 6
    • 0020078065 scopus 로고
    • In vivo comparison of levothyroxine preparations
    • Ramos-Gabatin A, Jacobson JM, Young RL. In vivo comparison of levothyroxine preparations. JAMA 1982; 247: 203-5
    • (1982) JAMA , vol.247 , pp. 203-205
    • Ramos-Gabatin, A.1    Jacobson, J.M.2    Young, R.L.3
  • 7
    • 0018833590 scopus 로고
    • Nonequality of brand name thyroxine preparations
    • Jacobson JM, Ramos-Gabatin A, Young RL, et al. Nonequality of brand name thyroxine preparations [letter]. JAMA 1980; 243: 733
    • (1980) JAMA , vol.243 , pp. 733
    • Jacobson, J.M.1    Ramos-Gabatin, A.2    Young, R.L.3
  • 8
    • 0018701902 scopus 로고
    • Drug substitution
    • Stoffer SS. Drug substitution [letter]. JAMA 1979; 242: 1257
    • (1979) JAMA , vol.242 , pp. 1257
    • Stoffer, S.S.1
  • 9
    • 0018415997 scopus 로고
    • Substitution of levothyroxine products
    • Stoffer SS. Substitution of levothyroxine products [letter]. JAMA 1979; 241: 1229
    • (1979) JAMA , vol.241 , pp. 1229
    • Stoffer, S.S.1
  • 10
    • 0016353603 scopus 로고
    • Drug bioequivalence: Recommendations to the Office of Technology Assessment, Congress of the United States
    • Drug Bioequivalence Study Panel. Drug bioequivalence: recommendations to the Office of Technology Assessment, Congress of the United States. J Pharmacokinet Biopharm 1974; 2: 433-66
    • (1974) J Pharmacokinet Biopharm , vol.2 , pp. 433-466
  • 11
    • 10044297580 scopus 로고
    • Bioavailability of oral solid dosage forms and clinical response to drug therapy
    • Swarbrick J, editor. Philadelphia (PA): Lea & Febiger
    • Barr WH. Bioavailability of oral solid dosage forms and clinical response to drug therapy. In: Swarbrick J, editor. Current concepts in the pharmaceutical sciences: dosage form design and bioavailability. Philadelphia (PA): Lea & Febiger, 1973: 31-75
    • (1973) Current Concepts in the Pharmaceutical Sciences: Dosage Form Design and Bioavailability , pp. 31-75
    • Barr, W.H.1
  • 12
    • 0023617252 scopus 로고
    • Untersuchungen zur relativen bioverfügbarkeit von laevothyroxin-na nach oraler gabe
    • Ball P, Klinger W, Strubelt O. Untersuchungen zur relativen Bioverfügbarkeit von Laevothyroxin-Na nach oraler Gabe. Nuc-Compact 1987; 18: 92-6
    • (1987) Nuc-Compact , vol.18 , pp. 92-96
    • Ball, P.1    Klinger, W.2    Strubelt, O.3
  • 13
    • 0027103654 scopus 로고
    • A study in normal human volunteers to compare the rate and extent of levothyroxine absorption from Synthyroid® and Levoxine®
    • Berg JA, Mayor GA. A study in normal human volunteers to compare the rate and extent of levothyroxine absorption from Synthyroid® and Levoxine®. J Clin Pharmacol 1993; 33: 1135-40
    • (1993) J Clin Pharmacol , vol.33 , pp. 1135-1140
    • Berg, J.A.1    Mayor, G.A.2
  • 14
    • 0028951298 scopus 로고
    • Multiphasic thyrotropin responses to thyroid hormone administration in man
    • Spencer CA, LoPresti JS, Nicoloff JT, et al. Multiphasic thyrotropin responses to thyroid hormone administration in man. J Clin Endocrinol Metab 1995; 80: 854-9
    • (1995) J Clin Endocrinol Metab , vol.80 , pp. 854-859
    • Spencer, C.A.1    LoPresti, J.S.2    Nicoloff, J.T.3
  • 15
    • 0017342755 scopus 로고
    • Aspects of the absorption of oral L-thyroxine in normal man
    • Wenzel KW, Kirschsieper HE. Aspects of the absorption of oral L-thyroxine in normal man. Metabolism 1977; 26: 1-8
    • (1977) Metabolism , vol.26 , pp. 1-8
    • Wenzel, K.W.1    Kirschsieper, H.E.2
  • 16
    • 0016206806 scopus 로고
    • Evidence of lower toxicity during thyroxine suppression after a single 3-mg 1-thyroxine dose: Comparison to the classical 1-triiodothyronine test for thyroid suppressibility
    • Wenzel KW, Meinhold H. Evidence of lower toxicity during thyroxine suppression after a single 3-mg 1-thyroxine dose: comparison to the classical 1-triiodothyronine test for thyroid suppressibility. J Clin Endocrinol Metab 1974; 38: 902-5
    • (1974) J Clin Endocrinol Metab , vol.38 , pp. 902-905
    • Wenzel, K.W.1    Meinhold, H.2
  • 17
    • 0014956576 scopus 로고
    • A thyroid suppression test using a single dose of L-thyroxine
    • Wallack MS, Adelberg HM, Nicoloff JT. A thyroid suppression test using a single dose of L-thyroxine. N Engl J Med 1970; 283: 402-5
    • (1970) N Engl J Med , vol.283 , pp. 402-405
    • Wallack, M.S.1    Adelberg, H.M.2    Nicoloff, J.T.3
  • 23
    • 0030011772 scopus 로고    scopus 로고
    • Clinical comparison of three labelled-antibody immunoassays of free triiodothyronine
    • Piketty ML, d'Herbomez M, Le Guillouzic D, et al. Clinical comparison of three labelled-antibody immunoassays of free triiodothyronine. Clin Chem 1996; 42: 933-41
    • (1996) Clin Chem , vol.42 , pp. 933-941
    • Piketty, M.L.1    D'Herbomez, M.2    Le Guillouzic, D.3
  • 24
    • 0028967925 scopus 로고
    • The ACS: 180 As a thyroid function test analyzer
    • Price A, Bennett K, Giles M, et al. The ACS: 180 as a thyroid function test analyzer. Clin Chem Enzym Comm 1995; 6: 373-84
    • (1995) Clin Chem Enzym Comm , vol.6 , pp. 373-384
    • Price, A.1    Bennett, K.2    Giles, M.3
  • 25
    • 0028064465 scopus 로고
    • Automated and manual serum free thyroxine assays evaluated with equilibrium dialysis
    • Liewendahl K, Melamies L, Helenius T, et al. Automated and manual serum free thyroxine assays evaluated with equilibrium dialysis. Scand J Clin Lab Invest 1994; 54: 347-51
    • (1994) Scand J Clin Lab Invest , vol.54 , pp. 347-351
    • Liewendahl, K.1    Melamies, L.2    Helenius, T.3
  • 26
    • 0029051722 scopus 로고
    • Practical methodology of meta-analyses (overviews) using updated individual patient data
    • Stewart LA, Clarke MJ. Practical methodology of meta-analyses (overviews) using updated individual patient data. Stat Med 1995; 14: 2057-79
    • (1995) Stat Med , vol.14 , pp. 2057-2079
    • Stewart, L.A.1    Clarke, M.J.2
  • 28
    • 10044235818 scopus 로고    scopus 로고
    • Bioequivalence assessment of endogenous compounds like hormones: Eight levothyroxine (L-T4) formulations
    • Goeggelmann C, Clanget C, Ding R, et al. Bioequivalence assessment of endogenous compounds like hormones: eight levothyroxine (L-T4) formulations [abstract]. Eur J Clin Pharmacol 2002; 58: S94
    • (2002) Eur J Clin Pharmacol , vol.58
    • Goeggelmann, C.1    Clanget, C.2    Ding, R.3
  • 29
    • 0035076307 scopus 로고    scopus 로고
    • Comparative bioavailability of two oral L-thyroxine formulations after multiple dose administration in patients with hypothyroidism and its relation with therapeutic endpoints and dissolution profiles
    • Vaisman M, Spina LDC, Eksterman LF, et al. Comparative bioavailability of two oral L-thyroxine formulations after multiple dose administration in patients with hypothyroidism and its relation with therapeutic endpoints and dissolution profiles. Arzneimittel Forschung 2001; 51: 246-52
    • (2001) Arzneimittel Forschung , vol.51 , pp. 246-252
    • Vaisman, M.1    Spina, L.D.C.2    Eksterman, L.F.3
  • 30
    • 0032527327 scopus 로고    scopus 로고
    • Bioäquivalenz eines kombinationspräparates aus levothyroxin und jodid im vergleich zum monopräparat levothyroxin
    • Förster G, Hansen C, Mörsch F, et al. Bioäquivalenz eines Kombinationspräparates aus Levothyroxin und Jodid im Vergleich zum Monopräparat Levothyroxin. Med Klin (Munich) 1998; 93: 401-6
    • (1998) Med Klin (Munich) , vol.93 , pp. 401-406
    • Förster, G.1    Hansen, C.2    Mörsch, F.3
  • 31
    • 0030894813 scopus 로고    scopus 로고
    • Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism
    • Dong BJ, Hauck WW, Gambertoglio JG, et al. Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism. JAMA 1997; 277: 1205-13
    • (1997) JAMA , vol.277 , pp. 1205-1213
    • Dong, B.J.1    Hauck, W.W.2    Gambertoglio, J.G.3
  • 32
    • 0022623984 scopus 로고
    • L-thyroxine dosage: A re-evaluation of therapy with contemporary preparations
    • Hennessey JV, Evaul JE, Tseng YC, et al. L-thyroxine dosage: a re-evaluation of therapy with contemporary preparations. Ann Intern Med 1986; 105: 11-5
    • (1986) Ann Intern Med , vol.105 , pp. 11-15
    • Hennessey, J.V.1    Evaul, J.E.2    Tseng, Y.C.3
  • 34
    • 0023930552 scopus 로고
    • Wirksamkeitsunterschiede von levothyroxin-präparaten
    • Wenzel KW, Mehrländer U. Wirksamkeitsunterschiede von Levothyroxin-Präparaten. Dtsch Med Wochenschr 1988; 113: 53-8
    • (1988) Dtsch Med Wochenschr , vol.113 , pp. 53-58
    • Wenzel, K.W.1    Mehrländer, U.2
  • 39
    • 0028874532 scopus 로고
    • A pilot study on the determination of the relative bioavailability of levo-thyroxine
    • Trantow T, Herzog R, Fuder H, et al. A pilot study on the determination of the relative bioavailability of levo-thyroxine. Methods Find Exp Clin Pharmacol 1995; 17: 333-43
    • (1995) Methods Find Exp Clin Pharmacol , vol.17 , pp. 333-343
    • Trantow, T.1    Herzog, R.2    Fuder, H.3
  • 40
    • 0021750582 scopus 로고
    • Seasonal variation in plasma glucose and hormone levels in adult men and women
    • Behall KM, Scholfield DJ, Hallfrisch JG, et al. Seasonal variation in plasma glucose and hormone levels in adult men and women. Am J Clin Nutr 1984; 40: 1352-6
    • (1984) Am J Clin Nutr , vol.40 , pp. 1352-1356
    • Behall, K.M.1    Scholfield, D.J.2    Hallfrisch, J.G.3
  • 41
    • 0029006622 scopus 로고
    • Acclimation of a non-indigenous sub-artic population: Seasonal variation in thyroid function in interior Alaska
    • Levine M, Duffy L, Moore DC, et al. Acclimation of a non-indigenous sub-artic population: seasonal variation in thyroid function in interior Alaska. Comp Biochem Physiol 1995; 111A: 209-14
    • (1995) Comp Biochem Physiol , vol.111 A , pp. 209-214
    • Levine, M.1    Duffy, L.2    Moore, D.C.3
  • 43
    • 0023393723 scopus 로고
    • Seasonal variation in thyroid size in healthy males
    • Hegedüs L, Rasmussen N, Knudsen N. Seasonal variation in thyroid size in healthy males. Horm Metab Res 1987; 19: 391-2
    • (1987) Horm Metab Res , vol.19 , pp. 391-392
    • Hegedüs, L.1    Rasmussen, N.2    Knudsen, N.3
  • 44
    • 10044268936 scopus 로고    scopus 로고
    • Available from URL
    • The European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products (CPMP). Points to consider on adjustment for baseline covariates [online]. Available from URL: http://www.emea.eu.int/pdfs/ human/ewp/286399en.pdf [Accessed 2004 Oct 7]
    • Points to Consider on Adjustment for Baseline Covariates [Online]
  • 46
    • 1842482345 scopus 로고    scopus 로고
    • Testing the bioavailability of oral 1-thyroxine by studying its absorption: Smoke or mirrors?
    • Stockigt J. Testing the bioavailability of oral 1-thyroxine by studying its absorption: smoke or mirrors? Thyroid 2004; 14: 167-8
    • (2004) Thyroid , vol.14 , pp. 167-168
    • Stockigt, J.1


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