Preanalytical Considerations for Implementation of Microsampling Solutions

Collier, Bradley B.; Miesse, Peyton K.; Grant, Russell P.

doi:10.1002/9781119615583.ch3

Cited by 1 publication

(1 citation statement)

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“…26 PCS samples can also be sent to a CLIA (Clinical Laboratory Improvement Amendments)-certified laboratory for clinical chemistry analysis, ensuring compliance with stringent quality standards that can be critical in early-phase clinical trials for precise patient stratification and treatment effect determination. 27,28 F I G U R E 1 Transition from traditional venous blood collection at clinical site to patient-centric sampling at home.…”

Section: Advancing Clinical Studies With Pcsmentioning

confidence: 99%

Enhancing drug development and clinical studies with patient‐centric sampling using microsampling techniques: Opportunities, challenges, and insights into liquid chromatography‐mass spectrometry strategies

Chen,

Goudarzi,

Sikorski

et al. 2024

J Mass Spectrom

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Microsampling has revolutionized pharmaceutical drug development and clinical research by reducing sample volume requirements, allowing sample collection at home or nontraditional sites, minimizing animal and patient burden, and enabling more flexible study designs. This perspective paper discusses the transformative impact of microsampling and patient‐centric sampling (PCS) techniques, emphasizing their advantages in drug development and clinical trials. We highlight the integration of liquid chromatography‐mass spectrometry (LC–MS) strategies for analyzing PCS samples, focusing on our research experience and a review of current literatures. The paper reviews commercially available PCS devices, their regulatory status, and their application in clinical trials, underscoring the benefits of PCS in expanding patient enrollment diversity and improving study designs. We also address the operational challenges of implementing PCS, including the need for bridging studies to ensure data comparability between traditional and microsampling methods, and the analytical challenges posed by PCS samples. The paper proposes future directions for PCS, including the development of global regulatory standards, technological advancements to enhance user experience, the increased concern of sustainability and patient data privacy, and the integration of PCS with other technologies for improved performance in drug development and clinical studies. By advancing microsampling and PCS techniques, we aim to foster patient‐centric approaches in pharmaceutical sciences, ultimately enhancing patient care and treatment efficacy.

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Section: Advancing Clinical Studies With Pcsmentioning

confidence: 99%