Bioequivalence studies: need for the reability of generic drugs

Authors

  • Olga Laosa Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.
  • Pedro Guerra Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.
  • Jose Luis López-Durán Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Médico especialista en Farmacología Clínica.
  • Beatriz Mosquera Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Licenciada en Ciencias Químicas.
  • Jesús Frías Centro de Farmacología Clínica, Departamento de Farmacología y Terapéutica, Facultad de Medicina, Universidad Autónoma de Madrid. Madrid, España. Servicio de Farmacología Clínica, Hospital Universitario la Paz. Madrid, España. Médico especialista en Farmacología Clínica.

DOI:

https://doi.org/10.17843/rpmesp.2009.264.1419

Keywords:

Medicamentos genéricos, Política de medicamentos genéricos, Equivalencia terapéutica, Ensayos clínicos como asunto, Área bajo la curva

Abstract

A generic medicine is a pharmaceutical product containing an active ingredient already known and previously developed and invented by others. The cost of these generic or multisource products should be less than their counterparts original. The clinical effects and the risk-benefit balance of a medicine do not depend exclusively on the activity of a pharmacologically active substance. Demonstration of bioequivalence of generic medicine is of great importance. In Europe and the United States generic medicine approval is based in the demonstration of bioequivalence through comparative bioavailability studies in vivo. These arguments are required for marketing approval of generic medicines by the European and North American health authorities. As a measure of the amount of drug absorbed it is used the area under the curve concentrationtime (AUC), and as an indicator of the rate of absorption it is measured the peak concentration (Cmax) reached in the concentration-time curve and the time for its occurrence (Tmax). It is known as bioequivalence between two products when they have a comparable bioavailability in the appropriate experimental conditions. The ultimate goal of this process is to make quality drugs available to society and contribute to a more rational use of economic resources in the health system.

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Published

2009-12-31

Issue

Section

Symposium

How to Cite

1.
Laosa O, Guerra P, López-Durán JL, Mosquera B, Frías J. Bioequivalence studies: need for the reability of generic drugs. Rev Peru Med Exp Salud Publica [Internet]. 2009 Dec. 31 [cited 2024 Dec. 9];26(4). Available from: https://rpmesp.ins.gob.pe/index.php/rpmesp/article/view/1419