Clinical pharmacology approaches to the assessment of novel drug delivery concepts

Abstract

Clinical pharmacology evaluation plays a unique and vital role in the design of novel drug delivery systems. The purpose of this review is to describe how clinical pharmacology principles and methodologies can be applied to the study and development of drug delivery approaches and novel delivery systems. Buccal, nasal, transdermal, rectal and infusion pump delivery systems are discussed, along with the physiological implications of circadian variability and zero-order delivery, and the use of intestinal intubation and gamma scintigraphy methods. Basic physiological and biochemical processes must be taken into account as first principles in the rational design of drug delivery systems. Clinical methodologies are currently available to aid in the design and to assess the performance of such systems.