Nature

Bioequivalence Studies and Adaptive Design Methods

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

Bioequivalence of Rebamipide Granules and Tablets in Healthy Adult Male Volunteers

Table III. Pharmacokinetic parameters for rebamipide following oral administration of granules or a tablet at a dose of 100mg in 27 healthy adult male volunteers [mean (SD)] ...
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

Unicycive Achieves Primary Endpoint in Pivotal Bioequivalence Study of Renazorb

LOS ALTOS, Calif., Dec. 28, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today ...
Pharmabiz

Health ministry amends NDCT Rules to enable faster commencement of BA/BE studies

Health ministry amends NDCT Rules to enable faster commencement of BA/BE studies: Gireesh Babu, New Delhi Thursday, January 29, 2026, 08:00 Hrs [IST] In an effort to enable faster ...
abc27

LAPIX Therapeutics Reports Positive Bioequivalence for Oral Capsule and New Safety Milestones in the LPX-TI641 Program

LAPIX has completed a bioequivalence study in healthy human volunteers evaluating the pharmacokinetics and exposure profile of the new solid-dose capsule relative to the Phase I liquid solution. The ...
Benzinga.com

Eton Pharma Plans FDA Filing For ET-600 Oral Desmopressin Next Month, Eyes 2026 Launch

On Friday, Eton Pharmaceuticals, Inc (NASDAQ:ETON) revealed results from its bioequivalence study of ET-600, a proprietary, patented oral solution of desmopressin under development for central ...
Seeking Alpha

Unicycive Therapeutics Announces Publication of Oxylanthanum Carbonate (OLC) Positive Bioequivalence Data in Clinical Therapeutics

LOS ALTOS, Calif., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics (UNCY), Inc. , a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” ...
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 ...
Insider Monkey

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

BioNxt Solutions Inc. (“BioNxt” or the “Company”) (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in next-generation drug delivery technologies, is pleased to announce the launch ...
Business Wire

Harmony Biosciences Announces Positive Results From the Pivotal Bioequivalence Study for Pitolisant Gastro-Resistant Formulation

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced positive results from its pivotal bioequivalence (BE) study evaluating pitolisant ...