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Entreprise · 08/03/20011 min de lecture
Guidance for Industry on Levothyroxine Sodium Tablets-In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing; Availability
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Résumé
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.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →