ABSTRACT
This chapter explores the issues relevant to taking a medical imaging agent new chemical entity (NCE) into clinical trials. The position paper provides examples of microdosing clinical trails that might comprise the early characterization of an NCE by positron emission tomography imaging or using some other very sensitive analytical technique. The intent is to provide sufficient information to allow better communication between the various groups, including that with the regulatory authorities. The amount and type of information required prior to human testing is determined by the regulatory authorities responsible for the area in which the studies will take place. In the past there was a degree of variability in the requirements from country to country, but in the last decade the authorities have made efforts to develop a common set of requirements for the registration of new drugs. Medical imaging agents are generally governed by the same regulations as other drug and biological products.
