The Pediatric Challenge - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

The Pediatric Challenge
Can microdosing make medicines safer and more effective for children?

Pharmaceutical Technology
Volume 35, Issue 6, pp. 14

Stephanie Sutton
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.

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.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here