Microdosing: A Critical Assessment of Human Data
Journal of Pharmaceutical Sciences August 23, 2012 DOI: 10.1002/jps.23290 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | Microdosing |
| Keywords | Microdose Drug development Pharmacology Pharmacokinetics Medical physics |
| Citations | 51 |
| Key findings | Microdosing can provide pre-IND pharmacokinetic information for early candidate selection, but its predictive value for pharmacologic doses depends on the compound and requires critical assessment of clinical data. |
Abstract
Ultrasensitive analytical methodologies have now made possible the ability to characterize the pharmacokinetics (PK) of compounds following administration to humans of a minute, subpharmacologic dose, a microdose. This has the potential to provide pre-IND information to help in early candidate selection, but only if such information is reasonably predictive of PK at pharmacologic doses. The published clinical data in this area are critically assessed and perspectives drawn. The place of microdosing, alone and coupled with other innovative methodologies, both pre-IND and during clinical development, is considered as a way forward to improve the efficiency and informativeness of drug development.
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
Cited by 7
- Phase 0/microdosing approaches: time for mainstream application in drug development? Nature Reviews Drug Discovery September 8, 2020
- Microdosing and drug development: past, present and future Expert Opinion on Drug Metabolism & Toxicology April 4, 2013
- Phase 0, Including Microdosing Approaches: Applying the Three Rs and Increasing the Efficiency of Human Drug Development Alternatives to Laboratory Animals December 1, 2018
- Intra‐Target Microdosing (ITM): A Novel Drug Development Approach Aimed at Enabling Safer and Earlier Translation of Biological Insights Into Human Testing Clinical and Translational Science April 18, 2017
- The expanding utility of microdosing Clinical Pharmacology in Drug Development November 1, 2015
and 2 more in the library
Cites 8
- 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
- Identification of the Rate-Determining Process in the Hepatic Clearance of Atorvastatin in a Clinical Cassette Microdosing Study Clinical Pharmacology & Therapeutics August 10, 2011
- Microdosing Clinical Study: Pharmacokinetic, Pharmacogenomic (SLCO2B1), and Interaction (Grapefruit Juice) Profiles of Celiprolol Following the Oral Microdose and Therapeutic Dose The Journal of Clinical Pharmacology May 19, 2011
- The utility of microdosing over the past 5 years Expert Opinion on Drug Metabolism & Toxicology November 28, 2008
and 3 more in the library