Zdrowie i gospodarka · 13/02/2012

FDA Releases Draft Guidance on Bioequivalence Recommendations for Rifaximin Tablets

The Food and Drug Administration (FDA) has made available two draft guidances outlining specific guidance on the design of bioequivalence studies to support abbreviated new drug applications (ANDAs) for rifaximin tablets in two strengths: 200 mg (rifaximin-200) and 550 mg (rifaximin-550).