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 ...

Unicycive Achieves Primary Endpoint in Pivotal Bioequivalence Study ... 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.

The study marked the first time, to the authors’ knowledge, that researchers analyzed factors influencing the bioequivalence of insulin biosimilars based on structural equation models.

In this study, the application of criteria for bioequivalence without accounting for endogenous T 4 levels resulted in failure to identify differences between LT 4 products varying by as much as ...

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. The ...

Dublin, April 07, 2025 (GLOBE NEWSWIRE) -- The "Bioavailability and Bioequivalence Studies submitted in NDAs and INDs" training has been added to ResearchAndMarkets.com's offering.Attendees that need ...

Cite this: Are Bioequivalence Studies of Levothyroxine Sodium Formulations in Euthyroid Volunteers Reliable? - Medscape - Mar 01, 2004. Abstract and Introduction ...