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

Pre-study validation of the method was performed by documentation of specificity, linearity, limit of quantification, precision and accuracy.

In conclusion, this study reveals important flaws in the current design and analysis of single-dose crossover studies currently used to assess the bioequivalence of LT 4 products.

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

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 ...

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.

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 ...

Once commenced, the bioequivalence study is relatively short, scheduled for less than 30 days from start to finish. The Company plans to make further updates in the coming weeks regarding its ...

The company said its study met expectations and showed that the 600 mg dose of IkT-001Pro was equivalent to standard-of-care 400 mg imatinib mesylate.