Importance of Bioavailability/Bioequivalence (BE) studies
- Bioavailability studies are drug product performance studies
- The target of Bioequivalence studies is to evaluate the therapeutic compatibility of a drug formulation with pharmaceutical equivalents / alternatives.
- Monitoring of pharmacokinetic and pharmaco-dynamic parameters after administration of drugs under test.
Importance of BE studies have increased during the last four decades due to ;
- Large growth of drug production.
- Consumption of generic product which represent a large proportion of the whole consumption in a country.
- Its importance is recognized by the regulatory agencies of developed and developing countries.
- Considered as an essential part of the registration application submitted to a national regulatory authority