Intra‐Target Microdosing (ITM): A Novel Drug Development Approach Aimed at Enabling Safer and Earlier Translation of Biological Insights Into Human Testing
T. Burt, Robert J. Noveck, D. MacLeod, Anita T. Layton, Malcolm Rowland, Graham Lappin
Clinical and Translational Science April 18, 2017 DOI: 10.1111/cts.12464 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Theoretical or philosophical paper Peer reviewed |
|---|---|
| Topics | Microdosing |
| Key points | Proposes Intra-Target Microdosing (ITM), a drug development tool combining systemic subpharmacological microdosing with intratarget drug delivery, as a way to enable early, safe, and inexpensive detection of safety- and efficacy-relevant biomarkers and pharmacokinetic data with minimal risk. |
Abstract
The safe and efficient translation of biological insights into human applications is a major public health challenge. Safety concerns are associated with substantial preclinical developmental costs, delaying entry into first-in-human testing. We introduce a novel drug development tool, Intra-Target Microdosing (ITM), combining features of “microdosing,” the systemic subpharmacological testing of drugs, and intratarget drug delivery. The approach could enable early, safe, and inexpensive detection of safetyand efficacy-relevant biomarkers and pharmacokinetic data with minimal risk.
Comparable studies
Other theoretical and historical papers on microdosing, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Positron emission tomography microdosing: a new concept with application in tracer and early clinical drug development | 2003 | Theoretical or philosophical paper | |
| Set and setting in microdosing: an oft-overlooked principle. | 2022 | Theoretical or philosophical paper | |
| Psilocybin Microdosing Schedules, 5-HT2A Adaptation, and the Age-Dependent Cortical State: From Intermittent to Continuous Exposure | 2026 | Theoretical or philosophical paper | |
| Daily Psilocybin Microdosing as a Receptor-Adaptation Paradigm: A Testable 5-HT2A Down-Regulation Hypothesis | 2026 | Theoretical or philosophical paper | |
| It’s all about the relationship: The caregiver experience of supporting a person with advanced cancer going through an LSD microdosing trial Caregivers of advanced cancer patients in an LSD microdosing trial | 2026 | Theoretical or philosophical paper |
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
- Phase 0 trials/ Intra-Target-Microdosing (ITM) and the lung: a review BMC Pulmonary Medicine September 1, 2024
- 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 – A Novel Drug Development Approach: Proof of Concept, Safety, and Feasibility Study in Humans Clinical and Translational Science July 8, 2017
Cites 11
- Positron emission tomography microdosing: a new concept with application in tracer and early clinical drug development European Journal of Clinical Pharmacology September 1, 2003
- Big physics, small doses: the use of AMS and PET in human microdosing of development drugs Nature Reviews Drug Discovery February 28, 2003
- Microdosing and drug development: past, present and future Expert Opinion on Drug Metabolism & Toxicology April 4, 2013
- Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development Clinical and Translational Science February 26, 2016
- Microdosing Studies in Humans Drugs in R&D 2008
and 6 more in the library