Sometimes practical or ethical considerations dictate whether healthy volunteers or patients should be recruited for a particular study. But there are usually sound scientific arguments for collecting PK data from actual patients, to supplement or substitute for PK data obtained from healthy human volunteers during the first phases of drug development. Knowing to what extent the results obtained in healthy volunteers - if available - can be extrapolated to the intended treatment population is critical. The US FDA has recognized the importance of PK studies for determining drug concentration-time profiles in target patient populations...
Dear Industry Colleagues,
It is my privilege to update you on QPS' continuous growth and global expansion. At QPS, we appreciate opportunities to work with our clients and interact with industry colleagues in the scientific community. We know...