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Negocios · 15/5/19981 min de lectura
Guidance for Industry on Buspirone Hydrochloride Tablets In Vivo Bioequivalence and In Vitro Dissolution Testing; Availability
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Resumen
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Buspirone Hydrochloride Tablets In Vivo Bioequivalence and In Vitro Dissolution Testing.'' This is revision 1 of the guidance. The guidance has been revised to reflect the recent availability of buspirone hydrochloride tablets in 15-milligram dosage forms. Bioequivalence is tested using the highest available dosage of the reference listed drug. The revised guidance also notes the nonlinearity of buspirone at multiple-dosing.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →