Land O'Lakes Workshop on Microsampling: Enabling Broader Adoption.

Area of Science:

• Pharmacokinetics and Drug Development
• Bioanalytical Sciences
• Clinical Trial Methodology

Background:

• Microsampling technology offers a patient-centric alternative to traditional blood collection methods.
• The COVID-19 pandemic highlighted the critical need for remote and safe sampling techniques.
• Bridging studies are essential for validating microsampling methods against established protocols.

Framework:

• Recommendations cover optimal blood sampling sites (venous vs. capillary).
• Statistical approaches for correlation, concordance, and sample size determination are outlined.
• Guidance is provided on when to implement bridging studies for microsampling validation.

Implementation:

• Exploring opportunities and challenges associated with patient-centric sampling strategies.
• Integrating microsampling into clinical drug development workflows to improve efficiency.
• Addressing practical aspects of sample collection, handling, and analysis.

Implications:

• Facilitating broader adoption of microsampling to support patient needs and convenience.
• Transforming drug development from clinic-centric to patient-centric models.
• Enhancing patient safety and data integrity through advanced sampling technologies.