Microdosing Studies in Children: A US Regulatory Perspective
M Roth‐Cline, RM Nelson
Clinical Pharmacology & Therapeutics September 1, 2015 DOI: 10.1002/cpt.165 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Peer reviewed |
|---|---|
| Population | Children |
| Topics | Microdosing |
| Key points | Microdosing studies in children serve three purposes: obtaining pharmacokinetic information, studying the ontogeny of metabolic enzymes, and studying drug disposition. |
Abstract
Microdosing studies in children are used to obtain pharmacokinetic information, to study the ontogeny of metabolic enzymes, or to study drug disposition.
Citations in the library
Cited by 4
- Phase 0/microdosing approaches: time for mainstream application in drug development? Nature Reviews Drug Discovery September 8, 2020
- Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development Clinical and Translational Science February 26, 2016
- Phase 0, Including Microdosing Approaches: Applying the Three Rs and Increasing the Efficiency of Human Drug Development Alternatives to Laboratory Animals December 1, 2018
- Successful Use of [14C]Paracetamol Microdosing to Elucidate Developmental Changes in Drug Metabolism Clinical Pharmacokinetics February 2, 2017