Bioequivalence study results for Alpha-1062 – August 2022. For the second quarter of 2022 versus the same prior year period, both ending June 30. No revenues were generated in either period; ...

Renazorb demonstrates pharmacodynamic bioequivalence to Fosrenol Renazorb’s enhanced product profile features reduced pill burden and small, swallowable tablets, which may improve patient ...

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 ...

Shao H, Tao Y, Tang C. Factors influencing bioequivalence evaluation of insulin biosimilars based on a structural equation model. Front Pharmacol. Published online April 3, 2023. doi:10.3389/fphar ...

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 ...

[2] The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme. Journal of Pharmacy & Pharmaceutical ...

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.