Interpretation of BA/BE studies

DADA has supervised or monitored close to a 100 complete BA/BE projects and has evaluated many more bioequivalence studies conducted by other companies. Thus DADA has acquired a vast body of knowledge about this very specific subject. DADA has demonstrated that it is not only able to adequately monitor bioequivalence studies; it is also able to find creative solutions for non-standard problem situations.

Besides monitoring studies, DADA has also supported many companies when bioequivalence studies produced suboptimal or unexpected results. By creatively re-evaluating all available data, it was often possible to explain deviating test results and to provide satisfactory answers to questions raised by the regulatory authorities. This has resulted in a number of publications in peer reviewed scientific literature, confirming the state-of-the-art quality of services rendered by DADA.