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) ...
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 ...
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 ...
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 ...
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 ...
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.
The government has moved to significantly speed up the manufacturing of new and investigational drugs by halving the time required to review related applications, a step aimed at accelerating drug ...
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 ...
In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) ...
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) ...
(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% ...
Thirty-six volunteers (18 women and 18 men) between 19 and 50 years of age, inclusive, were enrolled. Subjects were clinically and biochemically euthyroid and in general good health based on the ...
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