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Adjusted indirect comparisons to assess bioequivalence between generic clopidogrel products in Serbia.

Zorica PejčićKatarina VucicevicAlfredo Garcia-ArietaBranislava Miljković
Published in: British journal of clinical pharmacology (2019)
This study demonstrates that the bioavailability of these 4 generic clopidogrel products authorised in Serbia is very similar. Despite the limited power of AICs, bioequivalence was demonstrated for all 90% CIs of AUC0-t and all 90% CIs of Cmax comparisons were within or very close to the acceptance range, being able to comply with the acceptance criterion employed in Canada for Cmax . Therefore, these 4 generic clopidogrel products authorised in Serbia can be considered switchable with each other in clinical practice based on the adjusted indirect comparisons.
Keyphrases
  • acute coronary syndrome
  • percutaneous coronary intervention
  • antiplatelet therapy
  • clinical practice