Guidance for Industry on Buspirone Hydrochloride Tablets In Vivo Bioequivalence and In Vitro Dissolution Testing; Availability

摘要

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.