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New FDA Draft Guidance on REMS and Bioequivalence Studies: Does New Procedure Secure ANDA Applicants The Right to Obtain Samples?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

Biohaven Doses First Subject in Pivotal Bioequivalence Study with Sublingual BHV-0223

NEW HAVEN, Conn., Nov. 6, 2017 /PRNewswire/ -- (NYSE: BHVN) - Biohaven Pharmaceutical Holding Company Ltd. ("Biohaven" or the "Company") and its wholly owned subsidiary, Biohaven Pharmaceuticals, Inc.
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) ...
Mena FN

Bioequivalence Studies Market To Hit US$ 1349.06 Million By 2033, North America Led 43.5% Of Global Market Share.

(MENAFN- EIN Presswire) EINPresswire/ -- The global Bioequivalence Studies Market size was US$ 701.70 Million in 2024 and is expected to reach US$ 1349.06 Million by 2033, growing at a CAGR of 7.5% ...
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 ...
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 ...
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 ...