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TSH-Based Protocol, Tablet Instability, and Absorption Effects on L-T(4) Bioequivalence

BACKGROUND: FDA Guidance for pharmacokinetic (PK) testing of levothyroxine (L-T(4)) for interbrand bioequivalence has evolved recently. Concerns remain about efficacy and safety of the current protocol, based on PK analysis following supraphysiological L-T(4) dosing in euthyroid volunteers, and rece...

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Detalhes bibliográficos
Main Authors: Eisenberg, Marisa, DiStefano, Joseph J.
Formato: Artigo
Idioma:Inglês
Publicado em: Mary Ann Liebert, Inc. 2009
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC2858298/
https://ncbi.nlm.nih.gov/pubmed/19191742
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1089/thy.2008.0148
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