JD Supra

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 ...

The U.S. Food and Drug Administration (FDA) issued final guidance on “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides advice on conducting bioequivalence (BE) ...
Yahoo Finance

BioNxt Launches 15-day Sublingual Cladribine Dosing Optimization Study in Preparation for Human Bioequivalence Study

VANCOUVER, BC / ACCESS Newswire / October 21, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in next-generation drug ...
PharmiWeb

Innovative Methodology Enhances Bioequivalence Studies and Advances Anemia Treatment

Anemia is a serious medical condition affecting millions of people worldwide, characterized by a lack of healthy red blood cells to carry adequate oxygen to the body's tissues. This condition can lead ...
The American Journal of Managed Care

Study Identifies Factors That Influence Bioequivalence Evaluations of Insulin Biosimilars

These factors could provide a scientific basis for consistency evaluations of the quality and efficacy of insulin biosimilars, study authors wrote. Factors that may affect the bioequivalence of test ...
Nasdaq

BioNxt Solutions Prepares for Human Bioequivalence Study For MS

VANCOUVER, BC/ ACCESS Newswire/ April 23, 2025/ BioNxt Solutions Inc., a bioscience innovator specializing in advanced drug delivery systems, is pleased to report advanced preparation for its human ...