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 = ...

Detailed information of the methods used in these two studies has been described elsewhere. 9 A summary of the methods is presented below. Bioequivalence studies were carried out in a standard ...

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 determination of topical bioequivalence requires a multi-faceted approach, tailored specifically to the generic-drug formulation. For a new generic-drug product to be approved by a regulatory ...

Anemia is a serious medical condition affecting millions of people worldwide, characterized by a lack of healthy red blood cells to carry adequate oxygen to the body's tissues. This condition can lead ...

Study Overview: Pfizer is running an early-stage trial to compare how two versions of the same migraine-related drug behave in the body. The official title is “A Phase 1, Open Label, Single Dose, ...