Microdosing project to help develop drugs for infants

Most of the medicine prescribed to children have been developed and tested for adults, even though--as reported previously here--kids have smaller airways, less protective muscle around their organs, greater body to surface area to body mass ratio, along with a higher metabolic rate, lower blood pressure, faster heart rate and a less mature immune system. Pediatricians generally are forced to resort to off-label use and estimated dosing. In Europe, though, there is a program to try to remedy this problem through microdosing studies, and it just received a $1.7 million shot in the arm through a research grant.

Drug Discovery & Development reports that the program will use accelerator mass spectrometry to measure the drug concentration in these small blood volumes. The program goes by the acronym PAMPER (Pharmaceutical Accelerator Mass Spectrometry Microdose Pediatric Evaluation Research Study). PharmTechTalk's Stephanie Hutton spoke with Wouter Vaes, who is responsible for early clinical development at TNO, which is participating in the project. Vaes expects microdosing to eventually be used to test drugs for all ages.

"Eventually, we expect that microdosing will be used to derive kinetic and metabolic information for all age groups at the same time," Vaes told Hutton. "This information can be used to derive appropriate dosing regimes for further pediatric investigations. One of the important issues that the consortium will address is to develop methodology to determine the extremely low concentrations in tiny blood samples using the accelerator mass spectroscopy at the TNO."

- read the story in Drug Discovery & Development
- and Hutton's interview with Vaes in PharmTechTalk