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Zdrowie i gospodarka · 24.12.2014

Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for methylphenidate hydrochloride (HCl) extended- release oral suspension.

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