Levothyroxine dosage and the limitations of current bioequivalence standards

Author:

Hennessey James V

Publisher

Springer Science and Business Media LLC

Subject

Endocrinology,Endocrinology, Diabetes and Metabolism

Reference10 articles.

1. Hennessey JV (2003) Levothyroxine a new drug? Since when? How could that be? Thyroid 13: 279–282

2. US Department of Health and Human Services, FDA, and Center for Drug Evaluation and Research (2002) Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products—general considerations [ http://www.fda.gov/cder/guidance/4964dft.pdf ] (accessed 19 July 2006)

3. FDA (2005) Itinery for the joint public meeting on equivalence of levothyroxine sodium products [ http://www.fda.gov/ohrms/dockets/dockets/05n0137/05n-0137-lst0001.pdf ] (accessed 19 July 2006)

4. FDA (2005) Code of federal regulations, title 21, vol 5, subchapter D, part 320 [ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=320&show ] (accessed 19 July 2006)

5. Carr D et al. (1988) 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. Clin Endocrinol 28: 325–333

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