Levothyroxine for Hypothyroidism: Current Status of Biowaiver and Bioequivalence Studies

Journal Title: International Archives of Clinical Pharmacology - Year 2017, Vol 3, Issue 1

Abstract

Hypothyroidism is a common disease that needs to be closely treated, in order to reduce adverse symptoms and pathophysiological effects. For thyroid hormone replacement is preferred a therapy with a synthetic form of thyroxine (levothyroxine), a drug recognized by its Narrow Therapeutic Index. Generic levothyroxine can be an economic alternative for Hypothyroidism treatment. However, bioequivalence studies with levothyroxine are considered controversial. The aim of this review is to discuss aspects related to bioequivalence and biowaiver studies for levothyroxine considering the point of view of various regulatory agencies worldwide. Also, alternative strategies are proposed to perform bioequivalence with this drug.

Authors and Affiliations

Keywords

Related Articles

Unacceptable Intravenous Administration of Chloral Hydrate Oral Solution

Chloral hydrate is very frequently used in medical procedures with the purpose of sedation. After oral or rectal administration, central nervous system (CNS) and respiratory depression, cardiac arrhythmia and gastric irr...

Case Report: Addition of Naltrexone and Bupropion to Lorcaserin to Manage Olanzapine-induced Weight Gain

Antipsychotic medications, both typical and atypical, share the potential side effect of weight gain with atypical agents carrying a greater risk. Atypical antipsychotics, such as clozapine and olanzapine, which antagoni...

Mass Dose Effects of Carfentanil and Raclopride on Venous Plasma Cortisol and Prolactin after Tobacco Smoking during PET Scanning

Mass dose effects of the PET radioligands [11C] carfentanil and [11C] raclopride were determined on venous plasma cortisol and prolactin levels before and after tobacco smoking in overnight abstinent healthy male smokers...

Increase in Carbamazepine Serum Levels in Patient Treated with Voriconazole

The addition of voriconazole to chronic treatment with carbamazepine 400 mg twice a day was associated with increased carbamazepine serum levels (14.1 mg/l) and serum concentration dose ratios. Three days after the voric...

Dietary Flavonoids and Colorectal Cancer: Evidence from Epidemiological Studies

Identification of dietary agents related to colorectal carcinogenesis is of high importance to decrease the global burden of this severe disorder. As flavonoids abundantly present in plant-based food items are suggested...

Download PDF file
  • EP ID EP349297
  • DOI 10.23937/2572-3987.1510009
  • Views 112
  • Downloads 0

How To Cite

(2017). Levothyroxine for Hypothyroidism: Current Status of Biowaiver and Bioequivalence Studies. International Archives of Clinical Pharmacology, 3(1), 1-4. https://europub.co.uk/articles/-A-349297