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The FDA has updated its draft guidance on bioequivalence studies with fresh advice for developers of drugs in a range of dosage forms. Publication of the updated draft comes almost eight years after ...
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 ...
Medical research shapes healthcare every day, but not all studies are created equal. Knowing the differences can help you feel more confident reading health information online and understanding what ...
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 ...
Bioequivalence study is a non-therapeutic study. Indian GCP defines non-therapeutic study as a study in which there is no anticipated direct clinical benefit to the subject(s). Such studies, unless an ...
PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced positive results from its pivotal bioequivalence (BE) study evaluating pitolisant ...
GENEVA, SWITZERLAND / ACCESS Newswire / October 29, 2025 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY) (Relief, or the Company), a biopharmaceutical company committed to ...
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