Land O’Lakes Workshop on Microsampling: Enabling Broader Adoption

Springer Science and Business Media LLC - Tập 22 - Trang 1-7 - 2020
Enaksha R Wickremsinhe1, Qin C. Ji2, Carol R. Gleason2, Melanie Anderson3, Brian P. Booth4
1Eli Lilly & Company, Indianapolis, USA
2Bristol-Myers Squibb Company, Princeton, USA
3Merck & Co., Inc., West Point, USA
4US FDA, CDER, Office of Translational Sciences, Office of Clinical Pharmacology, Silver Spring, USA

Tóm tắt

The microsampling workshop generated recommendations pertaining to blood sampling site (venous blood versus capillary blood), when to conduct a bridging study, statistical approaches to establish correlation/concordance and deciding on sample size, opportunities and challenges with patient-centric sampling, and how microsampling technology can enrich clinical drug development. Overall, the goal was to provide clarity and recommendations and enable the broader adoption of microsampling supporting patients’ needs, convenience, and the transformation from clinic-centric to patient-centric drug development. The need and adoption of away-from-clinic sampling techniques has become critical to maintain patient safety during the current COVID-19 pandemic.

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