Bioequivalence studies are an essential component in the development and approval of generic pharmaceutical products, ensuring that they perform similarly to their reference counterparts.

Methods Study Design and Inclusion Criteria. This phase I study (study code 398B6) was a single-dose, randomized, open label, three-treatment, three-period, three-sequence cross-over with a wash ...

In the present study, the application of either correction methods 2 or 3 and a narrowing of the statistical criteria range to 0.9 1.10 would allow differentiation of the two doses that differed ...

Subsequently, the developed methodology was applied in a bioequivalence study involving anemia patients. The in-study quality control results demonstrated that the method was highly accurate, with ...

VANCOUVER, BC / ACCESS Newswire / July 7, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC:XPHYF)(FSE:4XT), a bioscience innovator specializing in advanced drug delivery systems ...

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, Inc. announced positive results from its pivotal bioequivalence study of ET-600, a patented oral solution of desmopressin aimed at treating central diabetes insipidus.

VANCOUVER, BC / ACCESS Newswire / April 23, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery ...