News

Bioequivalence study of BH009 and Winthrop (docetaxel) injection (an authorized generic drug of Taxotere) in patients with advanced solid tumor: An open-label, randomized, single-dose, two-way ...
Syngene has embarked on evaluating bioequivalence of an injectable for type-2 diabetes and weight management. This was after a global pharma company was scouting for a partner to outsource its human ...
Bioequivalence was accepted if the calculated 90%-confidence intervals were within 0.80 - 1.25 for AUC t and within 0.75 - 1.33 for C max. Possible side effects of the study medication and any ...
This study was designed to investigate, in accordance with international regulatory guidelines, the bioequivalence of two omeprazole products following single- and multiple-dose administration, as ...
The abstract builds on the initial bioequivalence data from the first phase of the trial, published at EHA in June 2019 and reveals the final results from the ALLG APML5 bioavailability study ...
ZENEO® Methotrexate has met its objectives in a key bioequivalence study, enabling CROSSJECT to show the clinical effectiveness of its innovating product, also called "needle free injection".
Study 067-EG-011 was a randomized, open-label, single dose two period cross-over study that evaluated the bioequivalence of Egalet-001 60 mg compared to MS Contin 60 mg in 60 healthy subjects in a ...
The study enrolled 40 subjects per treatment arm. The study design, including the dose, primary endpoint, and sample size, was reviewed, and aligned by the FDA before the initiation of the study.
Syngene has embarked on evaluating bioequivalence of an injectable for type-2 diabetes and weight management. This was after a global pharma company was scouting for a partner to outsource its human ...