Bioequivalence and Bioavailability Forum

Hi all,

a new paper was published dealing with detection of data integrity issues in BE, in particular a type of fraud that is prevalent according to regulators. The manipulation does not leave a paper trail or audit trail, and is not necessarily visible by onsite inspection. But it can be visualised or detected by certain analyses.

Regulators have been making extensive use of analyses produced through the software software described in the paper ("Buster" and "SaToWIB" routines) and it has been used to raise potential serious risks to public health and thus for referral triggering.

You can find the paper here.