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Long-Term Imaging of Identified Neural Populations using Microprisms in Freely Moving and Head-Fixed Animals
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Microdosing: current and the future.

Graham Lappin1

  • 1Xceleron Inc., 20340 Seneca Meadows Parkway, Germantown, MD 20876, USA. graham.lappin@xceleron.com

Bioanalysis
|November 19, 2010
PubMed
Summary
This summary is machine-generated.

Microdosing drug development shows pharmacokinetic data scales to therapeutic doses in 80% of cases. This technique is expanding beyond predictions to study drug interactions and metabolism early in development.

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Area of Science:

  • Pharmacology
  • Drug Development
  • Clinical Pharmacology

Background:

  • Microdosing, a decade-old concept, involves administering sub-pharmacological doses of drugs.
  • Increasing research compares microdose pharmacokinetics to therapeutic dose pharmacokinetics.

Purpose of the Study:

  • To review the current applications and expanding role of microdosing in drug development.
  • To highlight microdosing's utility beyond pharmacokinetic prediction.

Main Methods:

  • Comparison of microdose pharmacokinetics with therapeutic dose pharmacokinetics.
  • Utilizing radiolabeled compounds ((14)C-drug) to assess drug metabolism and generate metabolic profiles.
  • Investigating drug-drug interactions by administering microdoses before and after enzyme modulators (e.g., cytochrome P450s).

Main Results:

  • Approximately 80% of publicly available microdose pharmacokinetic data scale within a twofold difference to therapeutic doses.
  • Microdosing enables early assessment of drug metabolism and potential drug-drug interactions.

Conclusions:

  • Microdosing is a valuable tool for predicting in vivo pharmacokinetics and informing early drug development decisions.
  • The application of microdosing is expanding into new areas, including drug metabolism, drug-drug interactions, and target engagement studies.