The FDA revises requirements for levothyroxine products

被引：10

作者：

Burman, Kenneth ^{[1
,2
]}

Hennessey, James ^{[3
]}

McDermott, Michael ^{[4
]}

Wartofsky, Leonard ^{[1
,2
]}

Emerson, Charles ^{[5
]}

机构：

[1] Georgetown Univ, Washington, DC 20057 USA

[2] Univ Hlth Sci, Bethesda, MD USA

[3] Harvard Univ, Sch Med, Boston, MA USA

[4] Univ Colorado, Denver, CO 80202 USA

[5] Univ Massachusetts, Worcester, MA 01605 USA

来源：

THYROID | 2008年 / 18卷 / 05期

关键词：

D O I：

10.1089/thy.2008.0109

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

引用

页码：487 / 490

页数：4

共 6 条

[1] Are bioequivalence studies of levothyroxine sodium formulations in euthyroid volunteers reliable? [J].

Blakesley, V ;

Awni, W ;

Locke, C ;

Ludden, T ;

Granneman, GR ;

Braverman, LE .

THYROID, 2004, 14 (03) :191-200

[2] Current methodology to assess bioequivalence of levothyroxine sodium products is inadequate [J].

Blakesley, VA .

AAPS JOURNAL, 2005, 7 (01) :E42-E46

[3]

Garber Jeffrey R, 2005, Endocr Pract, V11, P205

[4] Levothyroxine dosage and the limitations of current bioequivalence standards [J].

Hennessey, James V. .

NATURE CLINICAL PRACTICE ENDOCRINOLOGY & METABOLISM, 2006, 2 (09) :474-475

[5] Levothyroxine a new drug? Since when? How could that be? [J].

Hennessey, JV .

THYROID, 2003, 13 (03) :279-282

[6]

Wartofsky Leonard, 2002, Expert Opin Pharmacother, V3, P727, DOI 10.1517/14656566.3.6.727

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