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 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) ...
Dublin, April 07, 2025 (GLOBE NEWSWIRE) -- The "Bioavailability and Bioequivalence Studies submitted in NDAs and INDs" training has been added to ResearchAndMarkets.com's offering. Attendees that need ...
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 ...
WAYNE, Pa., June 25, 2015-- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative pain ...
Over 80% of U.S. drug prescriptions are for generic medicines. 1 Such medicines are an important part of the medical system, helping to alleviate drug shortages and improve access to affordable ...
Eton Pharmaceuticals, Inc. announced positive results from its pivotal bioequivalence study of ET-600, a patented oral solution of desmopressin aimed at treating central diabetes insipidus. The study, ...
VANCOUVER, BC / October 21, 2025 / BioNxt Solutions Inc. (“BioNxt” or the “Company”) (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in next-generation drug delivery technologies ...
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