The Pediatric Challenge

Medicines are often prescribed to children even though they have only been designed and tested in adults because of the ethical and practical issues associated with conducting pediatric trials. However, children's drug kinetics, metabolism, and dynamics can vary substantially compared with adults, which is why a consortium in Europe is exploring the potential of microdosing to obtain pharmacokinetic data that could be used to study new drugs. In particular, the consortium will be looking to improve drug development for infants (children aged 0–2 years) by using accelerator mass spectroscopy to overcome the main microdosing issue of measuring extremely low concentrations of drug candidates in tiny blood samples.

Stephanie Sutton

I found out more about this project during an interview with Wouter Vaes, who is responsible for early clinical development at the TNO in The Netherlands, one of the institutes involved in the consortium.

"Microdosing is one of the best tools that industry can choose to obtain human data at early stage in development," said Vaes. "Eventually, we expect that microdosing will be used to derive kinetic and metabolic information for all age groups at the same time."

If successful, the project could encourage greater uptake of microdosing. Microdosing provides data about a drug's pharmacokinetics and pharmacodynamics in humans at an early stage of development. With the potential to be a valuable drug development tool, microdosing is definitely a technology to keep an eye on.

Stephanie Sutton is an associate editor of Pharmaceutical Technology.