Jaganmohan Somagoni
ClinSync Clinical Research Private Limited, India
Title: Design of bioavailability and bioequivalence studies through PK-Stat approach
Biography
Biography: Jaganmohan Somagoni
Abstract
The concept of interchangeability of pharmaceutically equivalent drug products through bioequivalence test is not just a science but a noble idea to bring the drugs to a common man at an affordable cost. However, the study design and the way how the study is executed to prove that bioequivalence is a matter of concern to all the health authorities all over the world. In spite of an eagle eye watch with wide opened eyes by the pharma regulatory bodies on CROs and manufacturing companies, over the past 2-3 decades it has become evident that marketed products having the same amounts of the drug chemical entity are failing to demonstrate bioequivalence. In many cases, the reason behind the failure of the study is not an inefficient test formulation but inefficient study design. In view of the importance of the drug PK profile as a direct determinant of drug efficacy and safety a meticulous care has to be taken while designing the BE study so that the outcome of the study will be reliable and reproducible. The failure rate of BA/BE studies can be decreased drastically through combining the pharmacokinetic and statistical approaches. Therefore, an increased awareness of guidelines and training on the design of BE study with an appropriate PK-Stat approach will enhance the success rate of studies which will help the industry to launch better generic molecules. In addition, the increase in success rate of BE studies will also decrease unnecessary exposure of healthy subjects to investigational medications.