Biostudies; troubleshooting and lack of ICR justification

When bioequivalence studies fail to show equivalence of the test and reference drugs, it does not necessarily mean that the drugs are non-equivalent or that the study cannot be used. DADA has both in-house and external experts that can review the study data and determine the reasons for non-equivalence. Based on their analysis these experts can recommend further actions needed, whether it is returning to the formulation development, using different statistical methods for analysis of study data or anything in-between. For example, DADA has been the driving force behind the first generic registration of mesalazine tablets in Europe by successfully demonstrating that the current bioequivalence guidelines do not apply to this particular medicinal product. This resulted in a number of European marketing authorisations for our client, although the results of the bioequivalence study performed were out of standard specification.

DADA experts can evaluate old bioequivalence study reports that may need to be resubmitted for regulatory review (e.g. for new applicants or additional countries). Just recently, our experts have prepared numerous justifications for lack of Incurred Sample Reanalyses (ISR). The requirement to perform ISR has been introduced with the Guideline on bioanalytical method validation (EMEA/CHMP/EWP/192217/2009), which came into force on 1 February 2012.