The Pediatric Challenge - Pharmaceutical Technology

Latest Issue
PharmTech

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.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here