“Review: Application of Bioequivalence Testing of Medicines in Peru“
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Date
2022-11Author(s)
Alvarado, Angel T.
Gray, Vivian
Muñoz, Ana María
Saravia, María
Bendezú, María R.
Chávez, Haydee
García, Jorge A.
Ybañez-Julca, Roberto
Chonn-Chang, Andres
Basurto, Patricia
Pineda-Pérez, Mario
Salazar, Alberto
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“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.
“
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