A paper published in the AAPS journal in September found discrepancies with PK/PD data analysis software packages, with the authors pointing at Thermo Fisher Scientific’s platform Kinetica as potentially having an error which could mean some drugs were inaccurately approved by regulatory bodies.
At the time the company told in-Pharmatechnologist.com it was conducting a review of the system and in a letter sent to users of Kinetica– and provided to this publication by Helmut Schütz, one of the authors of the AAPS paper - the firm has said the internal investigation has confirmed the issues thrown up in the journal.
“The [AAPS] article discussed the validation of software used to assess bioequivalence and reported that results from Kinetica software differed from other software when unbalanced datasets were used,” the letter dated October 29 states.
“Kinetica software does employ an algorithm for a balanced design in both the cases of balanced and unbalanced studies. Therefore, any results from unbalanced studies would be inaccurate.”
While individual cases may differ, the firm believes that in most cases this error would result in only a small difference in the overall results, and the company is “currently implementing a software update and will be performing rigorous testing to ensure that this issue is resolved.”
Thermo Scientific has also sent a letter to the European Medicines Agency (EMA), Sophie Labbé a spokesperson from the regulator confirmed, telling us the issues raised by the paper were discussed by the CHMP’s Pharmacokinetic Working Party at its meeting on 21-22 October.
“The letter and the company’s intention to update the software will be considered by the Agency,” she told us, adding “the findings do not warrant immediate regulatory actions.”