Capillary microsampling in the regulatory environment: validation and use of bioanalytical capillary microsampling...

Area of Science:

• Bioanalytical Chemistry
• Pharmacokinetics
• Animal Research Ethics

Background:

• Capillary microsampling (CMS) aligns with the 3R principles for ethical animal use.
• Traditional large volume sampling poses ethical and practical challenges in bioanalysis.
• CMS offers a novel approach to biofluid collection and sample preparation.

Purpose of the Study:

• To clarify the validation and regulatory application of capillary microsampling methods.
• To review 5 years of experience using CMS for drug exposure determination in animal studies.
• To highlight the advantages of CMS in bioanalytical workflows.

Main Methods:

• Collection of precise biofluid volumes using capillary tubes.
• Dilution of microsamples prior to handling and analysis.
• Application of CMS in regulatory environments for drug exposure studies.
• Stabilization of labile analytes at the point of collection.
• Addition of internal standards to the whole sample for improved performance.

Main Results:

• CMS provides a validated method for drug exposure determination in animal plasma and blood.
• The method allows for immediate stabilization of labile analytes.
• Internal standard addition to the whole sample enhances analytical performance.
• CMS facilitates the use of existing bioanalytical laboratory equipment.

Conclusions:

• Capillary microsampling is a viable and ethical alternative to traditional sampling methods.
• CMS offers distinct advantages for handling labile analytes and improving analytical accuracy.
• This review provides guidance on validating and implementing CMS in regulatory settings.