When producing generic drugs, it is essential to prove that the performance of the generic drug product in vivo is equivalent to that of the originator. Generic drug makers face multiple hurdles to demonstrate the bioequivalence of the products under examination. At times, the influence of the drug substance on this are underestimated. This training course aims to clarify how the physical and chemical properties of a drug substance can be tuned and tailored to increase the chances of a successful bioequivalence study. We will also identify the critical specification parameters that have to be analysed for a better prediction of the study results.
This course is aimed at those who want to improve their general understanding of the factors that may influence or determine the outcome of a bioequivalence study. This includes both basic and more advanced levels of topics of interest to QA and QC professionals, staff from chemical production and development departments, and regulatory affairs personnel.
