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Microdosing: a critical assessment of human data.

Malcolm Rowland¹

¹Centre for Applied Pharmacokinetic Research, School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Manchester, UK. MRow190539@aol.com

Journal of Pharmaceutical Sciences

|August 29, 2012

Summary

Microdosing allows ultrasensitive pharmacokinetic (PK) analysis of subpharmacologic doses in humans. This approach can inform early drug candidate selection if PK data predict responses at pharmacologic doses, improving drug development efficiency.

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Area of Science:

Pharmacology and Pharmaceutical Sciences
Analytical Chemistry
Drug Development

Background:

Ultrasensitive analytical methods enable characterization of pharmacokinetics (PK) at subpharmacologic doses (microdoses).
Microdosing offers potential for pre-Investigational New Drug (pre-IND) information to aid early drug candidate selection.

Purpose of the Study:

To critically assess published clinical data on microdosing.
To evaluate the predictive value of microdose PK for pharmacologic doses.
To determine the role of microdosing in improving drug development efficiency.

Main Methods:

Critical assessment of published clinical data on microdose PK.
Analysis of the predictive accuracy of microdose PK for higher doses.
Consideration of microdosing in conjunction with other innovative methodologies.

Main Results:

Microdosing can provide valuable pre-IND information for candidate selection.
The predictive power of microdose PK for pharmacologic doses is a key consideration.
Microdosing shows promise for enhancing drug development.

Conclusions:

Microdosing, supported by ultrasensitive analytics, can inform early drug development decisions.
The utility of microdosing is contingent on its ability to predict PK at pharmacologic doses.
Integrating microdosing with other methods can improve the efficiency and informativeness of drug development.