Results from a TCD study : comparing generic Meropenem (Mercide®) with innovator brand (Meronem®)

Triclinium Clinical Development aided in the analysis and reporting of an in-practice study aimed at demonstrating therapeutic and bio-equivalence between a generic brand of meropenem and the innovator. The study demonstrated similar ex vivo efficacy and in vivo pharmacokinetics for the products under observation. Results suggest that the products are clinically interchangeable based on registration status, as well as bioassay results. A slightly higher observed generic meropenem AUC (approx. 4% higher) was observed, which is clinically acceptable due to a large therapeutic index.

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