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Zdrowie i gospodarka · 7.08.2002

Draft Guidance for Industry on Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision; Availability

The Food and Drug Administration is announcing the availability of a revised draft guidance for industry entitled "Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing." This draft guidance document provides recommendations to sponsors of abbreviated new drug applications (ANDAs) on the design of bioequivalence studies for modified-release dosage forms of potassium chloride.

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