Preclinical development of New Biological Entities (NBEs) such as human protein therapeutics requires considerable expenditure of time and costs. Poor prediction of pharmacokinetics in humans further reduces net efficiency. We here show for the first time that pharmacokinetic data of NBEs in humans can be successfully obtained early in the drug development process by the use of microdosing in a small group of healthy subjects combined with ultrasensitive Accelerator Mass Spectrometry (AMS).

 

(후략)