Zdrowie i gospodarka · 11.12.2014
Bioequivalence Recommendations for Budesonide Extended-Release Tablets; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Budesonide Extended-Release Tablets." The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for budesonide extended-release tablets.