References

1.SYNTHROID [package insert]. North Chicago, IL: AbbVie Inc.

2. American Thyroid Association. Hypothyroidism. A booklet for patients and their families.
http://thyroid.org/wpcontent/uploads/patients/brochures/Hypothyroidism_web_booklet.pdf. Published 2013.

3.Demers LM, Spencer CA, eds; National Academy of Clinical Biochemistry. Laboratory medicine practice guidelines: laboratory support for the diagnosis of thyroid disease https://www.aacc.org/-/media/Files/Science-and-Practice/Practice-Guidelines/Thyroid-Disease/ThyroidArchived2010.pdf. Accessed October 15, 2020.

4.Baskin HJ, Cobin RH, Duick DS, et al; for American Association of Clinical Endocrinologists. American
Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Hyperthyroidism and Hypothyroidism. Endocr Pract. 2002;8(6):457-469.

5.Yu LX, Jiang W, Zhang X, et al. Novel bioequivalence approach for narrow therapeutic index drugs. Clin Pharmacol Ther. 2015;97(3):286-291.

6.Garber JR, Cobin RH, Gharib H, et al. Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Endocr Pract. 2012;18(6):988-1028.

7.Data on file. IQVIA Top Branded Oral Rx Medication. AbbVie Inc. January 2018.

8.Lomenick JP, Wang L, Ampah SB, et al. Generic levothyroxine compared with Synthroid in young children with congenital hypothyroidism. J Clin Endocrinol Metab. 2013;98(2):653-658.

9.Data on file. Branded Drugs & Thyroid Market and Naturals. AbbVie Inc. 2015.

10.US Food and Drug Administration. Q&A on CGMPs. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm124740.htm.

11.US Food and Drug Administration. Current Good Manufacturing Practice Regulations. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm

12.Data on file. 37% Data. AbbVie Inc.

13.DMD Pharmacy Rx Analyst Audit Report 2017.

14.Delta Marketing Dynamics. DMD Synthroid Rx Audit Summary, August 2017.

15.US Food and Drug Administration. Approved Drug Products With Therapeutic Equivalence Evaluations. 40th ed. Rockville, MD: US Food and Drug Administration, Center for Drug Evaluation and Research; 2020.
https://www.fda.gov/media/71474/download. Accessed October 15th, 2020.

16.Canaris GJ, Manowitz NR, Mayor G, Ridgway EC. The Colorado thyroid disease prevalence study. Arch Intern Med. 2000;160:526-534.

17.Carr D, McLeod DT, Parry G, Thornes HM. Fine adjustment of thyroxine replacement dosage: comparison of the thyrotrophin releasing hormone test using a sensitive thyrotrophin assay with measurement of free thyroid hormones and clinical assessment. Clin Endocrinol (Oxf). 1988;28(3):325-333.

18.Alexander EK, Pearce EN, Brent GA, et al. 2017 Guidelines of the American Thyroid Association for the diagnosis and management of thyroid disease during pregnancy and postpartum. Thyroid. 2017;27(3):315-389.

19.Hollowell JG, Staehling NW, Flanders WD, et al. Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab. 2002;87(2):489-499.