Zdrowie i gospodarka · 08/06/2023
FDA Releases Draft Guidance on Demonstrating Bioequivalence for Poorly Soluble Medications
The FDA has announced the availability of a draft guidance for industry on demonstrating bioequivalence for generic Type A medicated articles containing poorly soluble active pharmaceutical ingredients with little systemic absorption, a challenge for blood-level studies.
Source: Federal Register — Food and Drug AdministrationOpen original release →