Dynamic of TSH Level Daring Replacement of Hypothyroidism with the new Form of L-thyroxine Berlin-Chemie

1. Фадеев В.В., Мельниченко Г.А. Гипотиреоз: Руководство для врачей. М.: РКИ Северо-пресс, 2002. (2-е изд., 2004).

2. American Association of Clinical Endocrinologists, the Endocrine Society and the American Thyroid Association (2005) Joint position statement on the use and interchangeability of thyroxine products (http://www.thyroid.org/professionais/advoca cy/04_12_08_thyroxine.html и http://www.thyroid.org/professionals/education/bioequivalence.html).

3. Approved Drug Products With Therapeutic Equivalence Evaluations. 23rd ed. 2003. FDA/CDER (http://www.fda.gov/cder/ob/docs/preface/ecpreface.htm)

4. Biondi B., Palmieri E.A., Lombardi G., Fazio S. Effects of subclinical thyroid dysfunction on the heart // Ann. Intern. Med. 2002. V. 137 P. 904-914.

5. Blakesley V.A. Current methodology to assess bioequivalence of levothyroxine sodium products is inadequate // AAPS J. 2005. V. 30. P. 42-46.

6. Braverman L.E., Utiger R.D. / Eds. Werner & Ingbar’s The Thyroid: A Fundamental and Clinical Text. 8th ed. Philadelphia, Pa: Lippincott Williams & Wilkins: 2000.

7. Carr D., McLeod D.T., Parry G., Thornes H.M. 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. 1988. V. 28. P. 325-333.

8. Data on file. Abbott Laboratories, 2003.

9. Demers L.M., Spencer C.A. NACB Laboratory Medicine Practice Guidelines - Laboratory support for the diagnosis and monitoring of thyroid disease // Thyroid. 2003. V. 13. P. 1-126.

10. FDA (2006). DrugsFDA (www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm).

11. FDA Advisory Committee for Pharmaceutical Science. Briefing Document-Levothyroxine Bioequivalence. Advisory Committee Meeting. March 12-13, 2003 http://www.fda.gov/ohrms/dockets/ac/03/briefing/3926B1_02_AAbbott%20.doc

12. Helfand M., Redfern C.C. Screening for thyroid disease: an update // Ann. Intern. Med. 1998. V. 129. P. 144-158.

13. Hennessey J.V. Levothyroxine dosage and the limitations of current bioequivalence standards // Nature Clinical Practice Endocrinol. Metab. 2006. V. 2. P. 474-475.

14. Paul T.L., Kerrigan J., Kelly A.M. et al. Long-term thyroxine therapy is associated with decreased hip bone density in premenopausal women // JAMA. 1988. V. 259. P. 3137-3141.

15. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry. Levothyroxine sodium tablets-in vivo pharmacokinetic and bioavailability studies and in vitro dissolution testing. Dec. 2000 (http://www.fda.gov/cder/guidance/3645fnl.pdf).

16. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Science, Office of Generic Drugs. Electronic Orange Book. (http://www/fda.gov/cder/ob), 2003.