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) ...
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 ...
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 ...
Medscape

Are Bioequivalence Studies of Levothyroxine Sodium Formulations in Euthyroid Volunteers Reliable?

The sensitivity and precision of bioequivalence assessments for LT 4 products need to be improved so that the designation of bioequivalence ensures therapeutic equivalence. One solution to this ...
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 ...
JD Supra

New FDA Draft Guidance on REMS and Bioequivalence Studies: Does New Procedure Secure ANDA Applicants The Right to Obtain Samples?

Applicants seeking approval of Abbreviated New Drug Applications (ANDAs) in most cases must perform bioequivalence studies comparing their proposed generic product to the innovator drug listed in the ...
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 ...
Nasdaq

Eton Pharma Reports Positive Results From Bioequivalence Study Of ET-600 - Quick Facts

(RTTNews) - Eton Pharmaceuticals (ETON) announced positive results from bioequivalence study of ET-600, a patented oral solution of desmopressin under development for the treatment of central diabetes ...
Business Wire

Alpha Cognition Announces Positive Topline Results from Bioequivalence Study with ALPHA-1062 in Development for Alzheimer’s Disease

VANCOUVER, British Columbia--(BUSINESS WIRE)--Alpha Cognition Inc. (TSX-V: ACOG) (OTCQB: ACOGF) (“Alpha Cognition,” or the “Company”), a biopharmaceutical company committed to developing novel ...
GEN

Reducing the Need for Clinical Bioequivalence Endpoint Studies

Raman Spectroscopy and MDRS Enable Determination of the Size and Shape of Specific Components Within a Multicomponent Blend Reviewing the recent approval of an abbreviated new drug application (ANDA) ...
Medscape

Are Bioequivalence Studies of Levothyroxine Sodium Formulations in Euthyroid Volunteers Reliable?

The mean age of the 18 men and 18 women in the study was 32.9 years, and all were of normal weight for height. The data for three subjects were excluded from pharmacokinetic analyses because they ...