Current methodology to assess bioequivalence for levothyroxine sodium products is inadequate

AAPS Journal

Volumn 7, Issue 1, 2005, Pages

  Blakesley, Vicky A ^a  

^a ABBOTT LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; LEVOTHYROXINE; LEVOTHYROXINE SODIUM; LIOTHYRONINE; PROTIRELIN; THYROID HORMONE; THYROTROPIN; THYROXINE;

AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CLINICAL TRIAL; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSE REGIMEN; HUMAN; HYPOTHYROIDISM; METHODOLOGY; STATISTICAL ANALYSIS; THYROID CANCER; UNITED STATES;

ADOLESCENT; ADULT; AGE FACTORS; AGED; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; BIOPHARMACEUTICS; CHEMISTRY, PHARMACEUTICAL; CHILD; CHILD, PRESCHOOL; COMORBIDITY; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUGS, GENERIC; FEMALE; GUIDELINES; HUMANS; HYPOTHYROIDISM; INFANT; INFANT, NEWBORN; MALE; MIDDLE AGED; PREGNANCY; PREGNANCY COMPLICATIONS; THERAPEUTIC EQUIVALENCY; THYROID GLAND; THYROTROPIN; THYROXINE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 27644542257     PISSN: 15221059     EISSN: 15221059     Source Type: Journal    
DOI: 10.1208/aapsj070105     Document Type: Article

References (9)

1. Food and Drug Administration. Guidance for Industry: Levothyroxine sodium tablets - In vivo pharmacokinetic and bioavailability studies and in vitro dissolution testing. Available at: http://www.fda.gov/cder/guidance/3645fnl.htm. Accessed December 3, 2004.
2. Scanlon MF, Toft AD. Regulation of thyrotropin secretion. In: Braverman LE, Utiger RD, eds. Werner & Ingbar's The Thyroid: A Fundamental and Clinical Text. 8th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2000:234-253.
3. Levoxyl [package insert]. St Louis, MO: Jones Pharma Incorporated; 2001.
4. Synthroid [package insert]. North Chicago, IL: Abbott Laboratories; 2002.
5. Demers LM, Spencer CA. The National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines. Laboratory support for the diagnosis and monitoring of thyroid disease. Available at: http://www.nacb.org/lmpg/thyroid_lmpg_pub.stm. Accessed December 3, 2004.
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7. Blakesley V, Awni W, Locke C, Ludden T, Granneman GR, Braverman LE. Are bioequivalence studies of levothyroxine sodium formulations in euthyroid volunteers reliable? Thyroid. 2004;14:191-200.
8. Food and Drug Administration. Guidance for Industry: Statistical approaches to establishing bioequivalence. Available at: http://www.fda.gov/cder/guidance/3616fnl.htm. Accessed December 3, 2004.
9. Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations (Orange Book). 24th ed. Available at: http://www.fda.gov/cder/ob/docs/preface/ectablec.htm. Accessed December 3, 2004.