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Microsampling—How it Can Influence Drug Development

Moderated by: Enaksha Wickremsinhe, Ph.D. (Eli Lilly and Company)

About the Webinar: Traditionally, large volumes of blood are collected for pharmacokinetic and toxicokinetic studies. The volumes are basically dictated by the type of collection devices (vacutainers) available as well as the sample size needed for all associated analysis. These volumes typically range from 0.5 to 2.0 mL in non-clinical species and 2 to 5 mL in clinical studies. The 3Rs initiative (reduce, replace, refine) has focused attention on collecting smaller volumes of blood – of for that matter – collecting only what is needed for bioanalysis and the purpose of the study. Advancements in instrumentation, ethical and practical concerns of sampling from pediatric and diseased populations, and minimizing the number of animals required for non-clinical assessments are in line with the 3Rs initiative and have heralded developments in microsampling. Dried blood spot (DBS) sampling and analysis is the most referenced approach but several other microsampling techniques have now been developed over the past decade and used to support both non-clinical and clinical studies.

The purpose of this event is to provide an update on what’s new with microsampling (novel techniques/devices), and how microsampling is being used to support the quantitation of drugs, metabolites and biomarkers in preclinical and clinical development. To conclude the seminar will present a “case-study” on an implementation of DBS on a late-stage clinical program to support population pharmacokinetic modeling and associated regulatory interactions. Staged implementation of in vitro and bioanalytical feasibility, demonstrating a quantitative relationship between the blood and plasma concentrations using population PK (bridging dataset) led to regulatory (FDA and EMA) concurrence with this approach.

Learning Objectives:
  • Understand what is microsampling and how/when can it be used.
  • Review currently implemented and novel techniques and devices.
  • Explore how to implement clinical studies using microsampling (DBS) and planning and executing in late-stage clinical studies.

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