Zdrowie i gospodarka · 20/07/2015

Bioequivalence Recommendations for Lubiprostone; Revised Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lubiprostone capsules entitled "Bioequivalence Recommendations for Lubiprostone." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lubiprostone capsules.