Biowaiver studies (in vitro) to establish equivalence of drugs

Authors

  • Iván Saavedra S. Laboratorio de Farmacocinética y Biodisponibilidad, Programa de farmacología Molecular y Clínica, ICBM y Centro de Investigaciones Farmacológicas y Toxicológicas. Facultad de Medicina. Universidad de Chile
  • Victor Iturriaga V. Laboratorio de Farmacocinética y Biodisponibilidad, Programa de farmacología Molecular y Clínica, ICBM y Centro de Investigaciones Farmacológicas y Toxicológicas. Facultad de Medicina. Universidad de Chile
  • Luz Ávila M. Laboratorio de Farmacocinética y Biodisponibilidad, Programa de farmacología Molecular y Clínica, ICBM y Centro de Investigaciones Farmacológicas y Toxicológicas. Facultad de Medicina. Universidad de Chile
  • Luis Quiñones S. Laboratorio de Farmacocinética y Biodisponibilidad, Programa de farmacología Molecular y Clínica, ICBM y Centro de Investigaciones Farmacológicas y Toxicológicas. Facultad de Medicina. Universidad de Chile

Keywords:

bioequivalence, drugs interchangeability, biowaiver

Abstract

In this review, the concepts, guidelines and proposals regarding the determination of therapeutic equivalence of similar drug products are analyzed from a national and international point of view. The scientific background of the in vitro biowaiver studies that may result in the interchangeability of multisource drug product that have been waived from the demonstration of in vivo bioequivalence studies is also explained. In order to explain the methods in biowaiver studies, results of dissolution kinetics are shown as well as the requirements to approve an in vitro biopharmaceutic center.

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Published

2011-06-24

How to Cite

Saavedra S., I. ., Iturriaga V., V., Ávila M., L. ., & Quiñones S., L. . (2011). Biowaiver studies (in vitro) to establish equivalence of drugs. Cuadernos Médico Sociales, 51(2), 66–79. Retrieved from https://cuadernosms.cl/index.php/cms/article/view/496

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