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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 ...
The FDA’s finding that the Impax/Teva generic Wellbutrin XL 300 is not the bioequivalent of the GSK product has narrowed the generic antidepressant market to four distributors. The FDA’s findings ...
Comparisons of AUCinf and Cmax between Phase 3 and phase 2b formulations, and planned commercial and Phase 2b formulations: 90% CI = 90% Confidence Interval; Ratio (Test/Reference); BE LL 90% CI = ...
Samchundang Pharm surged to the upper price limit early in trading on July 23. This sharp rise is attributed to strong buying interest following the news that the company had successfully completed a ...
Newman disagreed with the majority's narrow reading of the statute as focusing on bioequivalence testing by generic manufacturers, noting that the statute had been interpreted "expansively," and ...
Curtis & Coulter LLC, are under 3 weeks away from hosting their co-located Bioequivalence: Intersection Between Science & Regulatory Summit and Oral Drug Formulation Innovations Summit taking place on ...
CHICAGO, July 18, 2017 /PRNewswire/ -- In a significant move, the US Food and Drug Administration (FDA) is asking for public comments on bioequivalence testing of generic drugs, specifically novel ...
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