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Bioequivalence studies are an essential component in the development and approval of generic ... A type of adaptive design that permits early trial termination for efficacy or futility based ...
Company to Request Pre-NDA Meeting with U.S. Food and Drug Administration. WALTHAM, Mass., Sept. 30, 2021-- Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company focused on the ...
The study marked the first time, to the authors’ knowledge, that researchers analyzed factors influencing the bioequivalence of insulin biosimilars based on structural equation models.
Completed dosing of 3 of 4 planned cohorts; expect to complete study in the second quarter of 2023 BOSTON and ATLANTA, March 15, 2023 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT ...
FDA now recommends only one study to show bioequivalence for certain oral drug products - FDA also revises several hundred product specific guidances to align with ICH M13A BE standards ...
The NDA is also supported by iloperidone clinical trial data, which includes a 6-week trial, a 4-week trial (ClinicalTrials.gov Identifier: NCT00254202) and a long-term relapse prevention study ...