Perspectives on microsampling: DBS

The concept of microsampling and particularly the dried blood spot methodology has been widely known to the scientific community for considerable time. Yet, there is no formal standard approach available to date for the pharmaceutical community to benefit from, in its regulatory interactions. This article discusses the various aspects of these issues and provides a framework within which a standard set of procedures can be adopted. From the perspective of experience in working with both the global pharmaceutical industry currently and the US FDA in the past, the availability of measured guidance on issues affecting regulatory science is indeed invaluable....