We understand this by analysing the PK and PD profiles of the drug. The study participants in these trials can be paediatrics or adults, patients or healthy volunteers. The objectives of these studies vary from a simple Absorption, Distribution, Metabolism and Excretion (ADME) study to a complex Dose Proportionality study with parallel and/or crossover designs. Most of these trials are part of Phase I or II and the duration of the trials varies from couple of months to several years.

In this session, we present the importance of CP trials in the drug development and approval process, their objectives and corresponding study designs along with the commonly experienced challenges.