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Negócios · 08/03/20011 min de leitura
Guidance for Industry on Levothyroxine Sodium Tablets-In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing; Availability
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Resumo
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Levothyroxine Sodium Tablets--In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing." This guidance is intended to assist sponsors of new drug applications (NDA's) for levothyroxine sodium tablets who wish to conduct in vivo pharmacokinetic and bioavailability studies and in vitro dissolution testing for their products.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →