EMA to discuss possible glitch in Thermo bioequivalence software

Increased reliance on software to support aspects of drug development has simplified many tasks, but created the possibility that an IT glitch could have far-reaching implications. Now, the European Medicines Agency (EMA) is to discuss whether this situation has already happened.

The concerns relate to Thermo Fisher Scientific's ($TMO) Kinetica, a program for analyzing and reporting pharmacokinetic and pharmacodynamic data. Generic manufacturers and CROs use the software for assessing bioequivalence in clinical trials before making a decision on whether to use the data to support a regulatory submission. The software is widely used, but a paper published last month in the journal of the American Association of Pharmaceutical Scientists (The AAPS Journal) questioned its reliability.

EMA is taking the paper seriously enough to discuss it at an upcoming meeting, Reuters reports, and Thermo Fisher has begun its own review of issues raised in the AAPS paper. The issue centers on the confidence intervals generated by Kinetica in trials in which a different number of patients are in each arm, a situation that can arise when participants drop out. In this situation, the study's authors found Kinetica delivered "questionable results."

The severity of the situation and its downstream effects are unclear, but the paper's co-author Anders Fuglsang thinks it is significant. "It's an unprecedented situation," Fuglsang, a regulator turned pharmaceutical consultant, said. Potentially, generic drugs could have won approval on the basis of unreliable results--although bioequivalence data is only part of regulatory submissions--or been dropped by their developers on the strength of a questionable calculation.

- read Reuters' article
- and the The AAPS Journal abstract