Zdrowie i gospodarka · 20/09/2012
Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium Capsule; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Pentosan Polysulfate Sodium." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for pentosan polysulfate sodium capsule.
Source: Federal Register — Food and Drug AdministrationOpen original release →