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