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Zdrowie i gospodarka · 20/09/2012

FDA Releases Draft Guidance on Bioequivalence Recommendations for Pentosan Polysulfate Sodium Capsule

The Food and Drug Administration (FDA) has made available a draft guidance document outlining specific recommendations for designing bioequivalence studies to support abbreviated new drug applications (ANDAs) for pentosan polysulfate sodium capsules, a treatment for interstitial cystitis.

Source: Federal Register — Food and Drug AdministrationOpen original release →