Abstract
Objective: Interchangeability between generic drugs is required for switching a patient from one generic drug to another. For this purpose, meta-analysis is used between generic drugs based on data obtained from independent bioequivalence studies. Material and Methods: From 2005 to 2013, Naproxen pharmacokinetic data of clinical trials done by Novagenix Bio Analytical R&D Centre in Turkey were used. Seven studies were suitable for the criteria of meta-analysis. The 90% confidence intervals for the differences between the means of pharmacokinetic parameters, area under the curve (AUC0-tlast) and maximum plasma concentration (Cmax), were determined for each binary combinations of seven generic drugs by meta-analysis used in average bioequivalence. Results: Considering the 90% confidence intervals, 76.2% of the binary combinations for only Cmax and 66.7% of the binary combinations for only AUC0-tlast have been concluded as bioequivalent. 47.6% of the binary combinations have been fulfilled the bioequivalence criteria for both Cmax and AUC0-tlast. Conclusion: Since some of the generic drug combinations may not match the bioequivalence acceptable range, switching a patient from one generic drug to another is leading to a major safety concern.
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