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 ...
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 ...
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 ...
Multiple-Dose Studies Can Be a More Sensitive Assessment for Bioequivalence Than Single-Dose Studies
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 ...
Harmony Biosciences (HRMY) announced results from its bioequivalence study evaluating pitolisant gastro-resistant formulation. With findings from both the pivotal BE and dosing optimization studies, ...
A new guideline for conducting bioequivalence studies was adopted by the CPMP in January and it becomes fully effective as of August 2010. A new guideline 1 for conducting bioequivalence studies was ...
The agency describes the requirements for retaining reserve samples of test articles and reference standards used in an in-vivo bioavailability and in-vivo or in-vitro bioequivalence study. The ...
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