Capillary microsampling in nonclinical safety assessment: practical sampling and bioanalysis from a CRO perspective.

Area of Science:

• Toxicology and Pharmacology
• Bioanalytical Chemistry
• Laboratory Animal Science

Background:

• Microsampling offers the 3Rs benefits (Refinement, Reduction, Replacement) in animal research.
• There is an increasing industry demand for microsampling in regulatory toxicology due to its scientific advantages.
• Correlating study findings with systemic exposure is crucial for robust safety assessments.

Purpose of the Study:

• To provide an overview of capillary microsampling in regulatory toxicology.
• To discuss initial considerations, study design, and practical aspects of capillary microsampling.
• To explore the bioanalytical implications of microsampling for various analytes and applications.

Main Methods:

• Focus on capillary microsampling techniques.
• Discussion of practical considerations for sample collection and storage.
• Exploration of bioanalytical method validation challenges and solutions.

Main Results:

• Capillary microsampling aligns with the 3Rs principles in animal studies.
• It facilitates better correlation between toxicological findings and systemic exposure.
• The article addresses practical and bioanalytical challenges for implementation.

Conclusions:

• Capillary microsampling presents a viable and advantageous approach for regulatory toxicology.
• Consideration of study design and bioanalytical workflows is essential for successful implementation.
• Microsampling supports the analysis of diverse analytes, including peptides and large molecules, for biomarker applications.