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 language | English |
|---|---|
| Pages (from-to) | 220-226 |
| Number of pages | 7 |
| Journal | Dissolution Technologies |
| Volume | 29 |
| Issue number | 4 |
| DOIs | |
| State | Published - 2022 |
Bibliographical note
Funding Information:with fewer economic resources ?3?14?堀 By havingthat is唀 to beaccessible and available to thepopulation FUNDING bioequivalent multi?source drugs? Peruvian medicalThis work was supported by the Molecular Pharmacology specialists can prescribe them in clinical practice to Society of Peru and the International Research Network in demonstrate interchangeability with the innovative Pharmacology and Precision Medicine ? Human Medicine drug for a specific disease ?15 ? 堀 Bioequivalence and Peru?School ? of the San Ignacio de Loyola University ? Lima ?
Publisher Copyright:
© 2022, Dissolution Technologies Inc. All rights reserved.
Keywords
- Bioequivalence
- drug regulation
- in vitro tes
- multi-source drug
- reference drug