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Microdosing for early biokinetic studies in humans
K Stenström1, M Sydoff, S Mattsson
1Department of Physics, Division of Nuclear Physics, Lund University, PO Box 118, SE-221 00 Lund, Sweden. kristina.stenstrom@nuclear.lu.se
Radiation Protection Dosimetry
|February 20, 2010
Summary
Human microdosing, or
Area of Science:
- Pharmaceutical sciences
- Drug development
- Toxicology
Background:
- Microdosing allows early human testing of new drugs, potentially improving candidate selection.
- This approach may reduce drug development failures and the need for animal testing.
- Sub-pharmacological doses are used to enable early human studies.
Purpose of the Study:
- To explore the concept of human microdosing in pharmaceutical development.
- To focus on Accelerator Mass Spectrometry (AMS) as a key technology for microdosing.
- To discuss the current status and principles of AMS-based microdosing.
Main Methods:
- Utilizing sub-pharmacological amounts of drug substances.
- Employing advanced detection technologies like Accelerator Mass Spectrometry (AMS).
- Comparing AMS with other microdosing technologies such as PET and LC-MS/MS.
Main Results:
- Microdosing offers potential for earlier candidate selection and reduced attrition rates.
- AMS enables sensitive detection of sub-pharmacological doses in humans.
- The paper details the principles and current applications of AMS in microdosing studies.
Conclusions:
- Human microdosing (Phase 0) can accelerate drug development and reduce costs.
- AMS is a critical technology for the successful implementation of microdosing.
- Microdosing with AMS promises to enhance early-stage drug candidate evaluation.
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