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) ...

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 ...

LOS ALTOS, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today ...

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 ...

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 ...

RICHMOND, Va., July 10, 2008 Insmed Inc.(Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals forunmet medical needs, today announced that it has demonstrated thebioequivalence of ...

-Results Demonstrated Bioequivalence to the Currently Approved Oral Solid Formulation -Market for Topiramate in Oral Form is Greater than $800 million Annually DEER PARK, Ill., March 17, 2020 (GLOBE ...

This phase I study (study code 398B6) was a single-dose, randomized, open label, three-treatment, three-period, three-sequence cross-over with a wash-out period of 7-10 days. Patients were eligible ...

LYON & INDIANAPOLIS--(BUSINESS WIRE)--Regulatory News: Adocia (Euronext Paris: ADOC) (Paris:ADOC) and Eli Lilly and Company (NYSE: LLY) announced today the successful completion of a preliminary Phase ...

Objective: To evaluate the bioequivalence of two enteric-coated formulations of omeprazole, Losec ® (reference) and Omepradex ® (test). It is hypothesised that formulation differences may be ...