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 ...

Spaulding Clinical to Perform Bioequivalence Study for One of World’s Largest Pharmaceutical Companies. September 13, 2010 02:26 PM Eastern Daylight Time. WEST BEND, ...

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 ...

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 ...

Reassurance as to the bioequivalence of generic formulations of the antiepileptic drug lamotrigine with the branded product, Lamictal (GlaxoSmithKline), has come from a new study sponsored by the ...

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.

A new guideline 1 for conducting bioequivalence studies was adopted by the Committee for Proprietary Medicinal Products (CPMP) in January this year and it becomes fully effective as of 1 August 2010.