Alpha-1062 Extended-Release Bioequivalence Study Topline Results Results from the second bioequivalence study were shared with investors a few weeks ago on August 22, 2022.

Once commenced, the bioequivalence study is relatively short, scheduled for less than 30 days from start to finish.

This study was designed to investigate, in accordance with international regulatory guidelines, the bioequivalence of two omeprazole products following single- and multiple-dose administration, as ...

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 ...

Eton Pharmaceuticals reports successful bioequivalence of ET-600 and plans NDA submission in April 2025 for diabetes insipidus treatment.

Research from all publishers Recent investigations into bioequivalence have focused on refining pilot study methodologies and adaptive strategies to overcome inherent variability challenges.

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 ...

Cedric O’Gorman, MD, Chief Medical Officer of Alpha Cognition, commented, "We are delighted with these additional positive registrational bioequivalence results from our second study of our lead ...

These factors could provide a scientific basis for consistency evaluations of the quality and efficacy of insulin biosimilars, study authors wrote.

Fidson Healthcare Plc has announced plans to conduct a Bioequivalence study on the production of chewable formulation of Albendazole tablets in partnership with Liddie BE Limited, a leading ...