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Microdosing and drug development: past, present and future.

Graham Lappin¹, Robert Noveck, Tal Burt

¹University of Lincoln, Brayford Pool, Lincoln, LN6 7TS, UK. glappin@lincoln.ac.uk

Expert Opinion on Drug Metabolism & Toxicology

|April 5, 2013

Summary

This summary is machine-generated.

Microdosing, a decade-old drug development technique, provides early human pharmacokinetic data using safe, sub-pharmacologic doses. Current evidence suggests it

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Published on: December 11, 2016

Area of Science:

Pharmacokinetics
Drug Development
Translational Science

Background:

Microdosing uses sub-pharmacologic doses for early human pharmacokinetic data.
The concept has been established for 10 years, with ongoing exploration.

Purpose of the Study:

To comprehensively review the microdosing concept over the past decade.
To define and distinguish microdosing from similar early drug development approaches.

Main Methods:

Review of peer-reviewed literature on microdosing.
Analysis of current applications and future potential of microdosing.
Exclusion of microdosing studies utilizing positron emission tomography.

Main Results:

Microdosing provides exploratory pharmacokinetic (concentration-time) data.
Evidence indicates microdosing may outperform alternative methods in predicting human pharmacokinetics.

Conclusions:

Microdosing shows promise as a predictive tool for human pharmacokinetics.
Integration with physiologically based modeling could enhance prediction reliability.
Applications extend to drug-drug interactions, polymorphism, and site-of-action concentration assessment.