 |
 |

Bioequivalence of Levothyroxine Preparations: Issues of Science, Publication, and Advertising
Leslie J. DeGroot, MD
University of Chicago Chicago, Ill
JAMA. 1997;278(11):895.
 |
 |
| Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings. |
|
 |
 |
To the Editor.
—The central question about the article by Dr Dong and colleagues1 is whether this study proves bioequivalence between preparations. I believe it is entirely inadequate for that purpose. The overriding problem is that not 1 of the 22 patients studied was proven to be athyrotic. Certainly the 15 patients with presumed Hashimoto thyroiditis, without documented hypothyroidism, had residual thyroid function. Probably the 7 patients with a thyrotropin level greater than 15 mU/L at some time also could provide significant endogenous hormone. Comparisons in this study represent the response to a mixture of endogenously and exogenously supplied hormone in unknown proportions. A valid comparison of thyroxine preparations can only be done in subjects who are without functional thyroid tissue.
A second objection is to comparison of area under the curve (AUC) measurements, which, while logical for bioavailability of compounds that have rapid turnover, are useless for compounds
. . . [Full Text PDF of this Article]
Footnotes
Edited by Margaret A. Winker, MD, Senior Editor, and Phil B. Fontanarosa, MD, Senior Editor.
CiteULike Connotea Del.icio.us Digg Reddit Technorati Twitter
What's this?
|