Abstract
Microdose(MD)study is a new drug development technique aimed at assessing the pharmacokinetics by dosage of MD quantity(i. e. not more than either 100μg or 1/100 of estimated pharmacologically effective dose)on human subjects in the early stage of drug development. PET is recommended as a technique of MD study and is featured by injection of a radio-labeled PET drug to visualize organ pharmacokinetics.
Based on our experience, we have described the outline of PET MD study, including the synthesis of radio-labeled PET drugs, quality control and assurance based on cGMP, preclinical safety study before the first human dosage based on the regulator's MD guidance, PET data acquisition procedures for dosimetry, and challenges for designing and conducting PET MD studies in clinical trials.
