Bioanalytics for Human Microdosing
Bruce A. Buchholz, Miranda J. Sarachine Falso, Benjamin J. Stewart, Kurt W. Haack, Ted J. Ognibene, Graham Bench, Gary A. Salazar Quintero, Michael Malfatti, Kristen S. Kulp, Kenneth W. Turteltaub
Encyclopedia of Drug Metabolism and Interactions May 15, 2012 DOI: 10.1002/9780470921920.edm112 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | Microdosing |
| Key findings | The text states that low drug doses in microdose or phase 0 studies challenge routine bioanalytical quantitation, and that LC-MS is the most common and generally preferred technique when drug and metabolite concentrations are not low, while AMS offers the best sensitivity and precision and PET provides in vivo distribution images. |
Abstract
Abstract: Low drug doses used in microdose or phase 0 studies present quantitation challenges to routine bioanalytical methods. Liquid chromatography‐mass spectrometry (LC‐MS), accelerator mass spectrometry (AMS), and positron emission tomography (PET) are bioanalytical techniques used for analysis of phase 0 samples. LC‐MS is most common and generally preferred if drug and metabolite concentrations are not low. AMS has the best sensitivity and precision, while PET provides images of distributionin vivo.
Comparable studies
Other narrative reviews on microdosing, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Big physics, small doses: the use of AMS and PET in human microdosing of development drugs | 2003 | Review | |
| Phase 0/microdosing approaches: time for mainstream application in drug development? | 2020 | Review | |
| Microdosing and drug development: past, present and future | 2013 | Review | |
| Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development | 2016 | Review | |
| Expectancy Effects in Psychedelic Trials. | 2024 | Review |
Citations in the library
Cites 5
- Big physics, small doses: the use of AMS and PET in human microdosing of development drugs Nature Reviews Drug Discovery February 28, 2003
- Use of microdosing to predict pharmacokinetics at the therapeutic dose: Experience with 5 drugs Clinical Pharmacology & Therapeutics September 1, 2006
- Impact of microdosing clinical study — Why necessary and how useful? Advanced Drug Delivery Reviews October 14, 2010
- Microdosing Studies in Humans Drugs in R&D 2008
- Nonlinear Pharmacokinetics of Oral Quinidine and Verapamil in Healthy Subjects: A Clinical Microdosing Study Clinical Pharmacology & Therapeutics June 29, 2011