Over 80% of U.S. drug prescriptions are for generic medicines. 1 Such medicines are an important part of the medical system, helping to alleviate drug shortages and improve access to affordable ...
The FDA has updated its draft guidance on bioequivalence studies with fresh advice for developers of drugs in a range of dosage forms. Publication of the updated draft comes almost eight years after ...
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 = ...
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 ...
On Friday, the Food and Drug Administration announced a new pilot prioritization program for the review of abbreviated new drug applications that aims to spur and reward investment in U.S. drug ...
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 ...
It ordered Teva to conduct a bioequivalence test in patients who'd reported problems with the copycat form. Late last year, Teva stopped that study, saying it couldn't find enough patients. Meanwhile, ...
There are over 250 functional drugs manufacturing companies that need to sell the products they are making. Now, how are they selling these drugs? Medical representatives or promotional officers of ...
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