We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
A test for bioequivalence on a variable of interest is sometimes used to determine whether a site that may have been adversely affected by its past use is sufficiently similar to a control site for ...
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 ...
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 = ...
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 ...
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 ...
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 ...
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