Review: Application of Bioequivalence Testing of Medicines in Peru

Angel T. Alvarado, Vivian Gray, Ana María Muñoz, María Saravia, María R. Bendezú, Haydee Chávez, Jorge A. García, Roberto Ybañez-Julca, Andres Chonn-Chang, Patricia Basurto, Mario Pineda-Pérez, Alberto Salazar

Research output: Contribution to journalReview articlepeer-review

Abstract

This is a review of the current status of drug bioequivalence studies in Peru. A bibliographic search was conducted in PubMed (Medline database) for bioequivalence studies in Peru. Generic drugs constitute the basis of pharmacological requests in health care systems in Latin American countries. Peru has enacted laws and regulations that require bioequivalence studies of high health risk drugs and exemptions, based on international legislation, to be conducted in research centers accredited by the authority of Health. There is a list of 19 drugs that must demonstrate their therapeutic equivalence through in vivo or in vitro studies, of which 13 have shown bioequivalence in vivo, and 8 of those have shown bioequivalence in vitro. There is a challenge for health authorities to enforce the current legislation and an even greater challenge for pharmaceutical laboratories to demonstrate bioequivalence of multi-source drugs with the reference drug.

Original languageEnglish
Pages (from-to)220-226
Number of pages7
JournalDissolution Technologies
Volume29
Issue number4
DOIs
StatePublished - 2022

Keywords

  • Bioequivalence
  • drug regulation
  • in vitro tes
  • multi-source drug
  • reference drug

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