A glitch in bioequivalence software puts trial results in doubt

Observed glitches with Thermo Fisher's ($TMO) popular drug development software have led to concerns that data used to win approvals may have been faulty, and the company is working alongside regulators to figure out just how widespread the issue may be.

Thermo's offering, called Kinetica, is a program used to help determine bioequivalence--whether two agents have similar pharmacokinetic and pharmacodynamic profiles and can thus be used interchangeably. Such testing is particularly useful in developing generics but also plays a role in many facets of drug development.

However, in a paper published in the journal of the American Association of Pharmaceutical Scientists, researchers compared results from Kinetica with those of four competing technologies and found some alarming discrepancies, suggesting Thermo's software may be prone to unreliable results in certain situations.

No drugs are approved on the results of bioequivalence studies alone, but the potential for incorrect data passing undetected has alarmed regulators, and the European Medicines Agency is planning a meeting this week to go over the available information and determine what to do next, according to Reuters.

For its part, Thermo Fisher is undergoing an internal review of Kinetica, saying little beyond confirming that it is aware of the concerns.

- read FierceBiotechIT's take
- here's the Reuters story
- and the AAPS Journal abstract