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

作者: Enaksha R Wickremsinhe , Qin C. Ji , Carol R. Gleason , Melanie Anderson , Brian P. Booth

DOI: 10.1208/S12248-020-00524-2

关键词:

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

参考文章(25)
Vinod P Shah, Kamal K Midha, John WA Findlay, Howard M Hill, James D Hulse, Iain J McGilveray, Gordon McKay, Krys J Miller, Rabindra N Patnaik, Mark L Powell, Alfred Tonelli, CT Viswanathan, Avraham Yacobi, Bioanalytical method validation--a revisit with a decade of progress. Pharmaceutical Research. ,vol. 17, pp. 1551- 1557 ,(2000) , 10.1023/A:1007669411738
Theingi M. Thway, Mark Ma, Jean Lee, Bethlyn Sloey, Steven Yu, Yow-Ming C. Wang, Binodh DeSilva, Tom Graves, Experimental and statistical approaches in method cross-validation to support pharmacokinetic decisions Journal of Pharmaceutical and Biomedical Analysis. ,vol. 49, pp. 613- 618 ,(2009) , 10.1016/J.JPBA.2008.12.008
Abraham J. Wilhelm, Adinda Klijn, Jeroen C. G. den Burger, Otto J. Visser, Agnes I. Veldkamp, Jeroen J. W. M. Janssen, Eleonora L. Swart, Clinical validation of dried blood spot sampling in therapeutic drug monitoring of ciclosporin A in allogeneic stem cell transplant recipients: direct comparison between capillary and venous sampling. Therapeutic Drug Monitoring. ,vol. 35, pp. 92- 95 ,(2013) , 10.1097/FTD.0B013E31827D76CE
Mario L. Rocci, Viswanath Devanarayan, David B. Haughey, Paula Jardieu, Confirmatory reanalysis of incurred bioanalytical samples. Aaps Journal. ,vol. 9, ,(2007) , 10.1208/AAPSJ0903040
J. Martin Bland, Douglas G. Altman, Statistical methods for assessing agreement between two methods of clinical measurement International Journal of Nursing Studies. ,vol. 47, pp. 931- 936 ,(2010) , 10.1016/J.IJNURSTU.2009.10.001
J. Martin Bland, DouglasG. Altman, Statistical methods for assessing agreement between two methods of clinical measurement. The Lancet. ,vol. 327, pp. 307- 310 ,(1986) , 10.1016/S0140-6736(86)90837-8
Christopher Evans, Mark Arnold, Peter Bryan, Jeffrey Duggan, Christopher A James, Wenkui Li, Steve Lowes, Luca Matassa, Timothy Olah, Philip Timmerman, Xiaomin Wang, Enaksha Wickremsinhe, John Williams, Eric Woolf, Patricia Zane, Implementing Dried Blood Spot Sampling for Clinical Pharmacokinetic Determinations: Considerations from the IQ Consortium Microsampling Working Group Aaps Journal. ,vol. 17, pp. 292- 300 ,(2015) , 10.1208/S12248-014-9695-3
Christopher A Evans, Christopher Bruce, Gary T Emmons, Lori Gallenberg, Qin C Ji, Lewis B Kinter, Eunice Musvasva, Enaksha Wickremsinhe, Conference Report: DIA/PhRMA workshop on DBS sampling in the pharmaceutical industry: methodology, implementation & best practices. Bioanalysis. ,vol. 2, pp. 1355- 1359 ,(2010) , 10.4155/BIO.10.101
Katsuhiko Kuwa, Toshimasa Nakayama, Tadao Hoshino, Makoto Tominaga, Relationships of glucose concentrations in capillary whole blood, venous whole blood and venous plasma. Clinica Chimica Acta. ,vol. 307, pp. 187- 192 ,(2001) , 10.1016/S0009-8981(01)00426-0