Quality Control for Bioequivalence Studies

This paper from Scribd provides an informative look into quality control practices for Contract Research Organizations, specifically when conducting bioequivalence studies. It is obvious that quality control and assurance are important, especially for sponsors to have reassurance that studies are being conducted in compliance with regulatory requirements. The how is sometimes debatable. This paper operates on the premise that the best personnel for quality control in studies on subjects such as bioequivalence are scientists. As the article points out:

“Individuals appointed to manage quality should have the ability to understand the basic concepts underlying the activities being carried out and consequently audited, which improves the integrity of the study.”

While it also notes that it may be easy for scientists to get hung up on the details and overlook something basic, overall, the reward versus the risk is still high enough to support the trend of having “regulatory scientists as quality professionals.”