Capillary microsampling in clinical studies: opportunities and challenges in two case studies.

Area of Science:

• Pharmacokinetics and Drug Development
• Pediatric Clinical Pharmacology
• Microsampling Techniques

Background:

• Traditional blood sampling methods pose challenges in pediatric populations.
• Minimally invasive techniques are crucial for ethical and practical pediatric research.
• Pharmacokinetic (PK) studies are essential for optimizing pediatric drug dosage and efficacy.

Purpose of the Study:

• To evaluate the feasibility and utility of capillary microsampling (CMS) for pediatric PK studies.
• To assess the quality and analytical success of blood samples collected via CMS in children.
• To explore the application of CMS in diverse pediatric age groups and therapeutic areas.

Main Methods:

• Collected 15 μl whole blood samples using capillary microsampling from fingersticks or heelsticks.
• Applied CMS in two distinct pediatric multisite studies: mebendazole and a respiratory syncytial virus drug.
• Analyzed PK profiles from samples obtained at multiple timepoints (complete and sparse sampling designs).

Main Results:

• Complete PK profiles (7 timepoints) were achievable in children aged 1–16 years, despite some fingerstick sample contamination.
• Successful analysis of sparse PK samples (2 samples) in infants aged 1–24 months, even with incompletely filled capillaries.
• Demonstrated the potential for obtaining usable PK data across different pediatric age ranges and study designs.

Conclusions:

• Capillary microsampling (CMS) is a viable technique for pediatric pharmacokinetic sampling.
• CMS offers potential benefits for PK studies in pediatric populations, reducing invasiveness.
• Further optimization of CMS procedures may be necessary to address challenges like sample contamination and filling.