Levothyroxine dosage and the limitations of current bioequivalence standards

被引：21

作者：

Hennessey, James V. ^{[1
]}

机构：

[1] Brown Univ, Rhode Isl Hosp, Hallett Ctr Diabet & Endocrinol, Providence, RI 02903 USA

来源：

NATURE CLINICAL PRACTICE ENDOCRINOLOGY & METABOLISM | 2006年 / 2卷 / 09期

关键词：

D O I：

10.1038/ncpendmet0273

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

FDA regulation of levothyroxine formulations aims to ensure consistent drug content and bioavailability of brand name and generic products. This Viewpoint suggests that the pharmacokinetic measure of therapeutic equivalence in current use—measurement of total T4levels in the blood—might not be sufficiently reliable to achieve these goals.

引用

页码：474 / 475

页数：2

共 9 条

[1]

*AM ASS CLIN END E, 2005, JOINT POS STAT US IN

[2] 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

[3] FINE ADJUSTMENT OF THYROXINE REPLACEMENT DOSAGE - COMPARISON OF THE THYROTROPIN RELEASING HORMONE TEST USING A SENSITIVE THYROTROPIN ASSAY WITH MEASUREMENT OF FREE THYROID-HORMONES AND CLINICAL-ASSESSMENT [J].

CARR, D ;

MCLEOD, DT ;

PARRY, G ;

THORNES, HM .

CLINICAL ENDOCRINOLOGY, 1988, 28 (03) :325-333

[4]

(CDER), 2002, GUID IND BIOAV BIOEQ, P2002

[5]

*FDA, 2006, DRUGS FDA

[6]

*FDA, 2003, ADV COMM PHARM SCI 1

[7]

*FDA, 2005, IT JOINT PUBL M EQ L

[8]

Henderson JD, 2001, SOUTHERN MED J, V94, P16

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

Hennessey, JV .

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

← 1 →