COULD PUBLICATION OF BIOINEQUIVALENCE DATA DISCOURAGE FRAUDS ON BIOEQUIVALENCE TRIALS?

ABSTRACT

Generics is a well spread market in the USA and in some European countries, and is in a developmental phase in other countries. Literature in this field notices several cases of generics which proved to be bio-inequivalent with the originator. This could be the result of misconducted trials or, at least in some cases, of frauds. Bioinequivalent generics could create serious problems either of inactivity or toxicity in their therapeutic use. Publication of bioinequivalent data on marketed generics should be stimulated as they can give notice to the scientific audience of its relevance and could discourage these kinds of uncorrected procedures.

Key words: :

• Generic drugs
• Bioinequivalence
• Bioequivalence
• Frauds