Patient Centric Blood Sampling and Quantitative Analysis

Authoritative resource providing a complete overview of patient centric blood sampling, as well as its benefits and challenges

Patient Centric Blood Sampling and Quantitative Analysis focuses on the growing interest in alternative means to standard phlebotomy and analytical workflows for the collection and analysis of high-quality human biological samples for the quantitative determination of circulating drugs, their metabolites, and endogenous substances for clinical trials, routine healthcare and neonatal screening. The book clearly explains the benefits and constraints of having patients collect small volumes of blood in locations outside of a clinic (e.g at home), including: patient convenience; less invasive procedures; increased frequency of sampling; applicability to collecting samples from the young, elderly, and those in remote locations; greater frequency; and lower cost per sample. Readers will learn about approaches for successfully implementing patient centric sampling workflows in a number of scenarios, including the clinical setting and in the analytical laboratory.

Edited by four recognized experts in this field, with additional specialists in the discipline enlisted to write the component chapters, enabling greater depth and detail to be added and further raising the scientific standing of the publication, Patient Centric Blood Sampling and Quantitative Analysis includes information on:

• Basics of patient centric blood sampling and techniques and approaches that are available and in development for the collection and analysis of the samples
• Science behind patient centric blood sampling and its implications regarding human healthcare and wellbeing
• Application areas of patient centric sampling, including drug development, clinical chemistry/pathology, therapeutic drug monitoring, and more
• Practical approaches to successful implementation for existing and developing purposes and workflows, and case studies to support implementation within an organization

Giving the reader a broad understanding of what patient centric sampling is and where it might be applied for existing and potential future areas, Patient Centric Blood Sampling and Quantitative Analysis is an essential resource on the subject for many different types of laboratories, areas of clinical research and healthcare, including those in pharmaceutical, clinical, and research functions.

Neil Spooner, Ph.D., C.Chem., F.R.S.C., is the Founder of Spooner Bioanalytical Solutions and the Patient Centric Sampling Interest Group (PCSIG) where he champions the implementation of patient centric sampling approaches. Dr Spooner is also the Editor In Chief of Bioanalysis Journal and is a Senior Visiting Research Fellow at the University of Hertfordshire, UK.

Emily Ehrenfeld is President of New Objective, Inc, an industry leader in high performance nano/microflow technologies.

Joe Siple is Director, Corporate Relations for New Objective, Inc., an industry leader in high performance nano/microflow technologies.

Mike Lee, PhD, is the founder of the Annual Symposium on Clinical and Pharmaceutical Solutions and Analysis (CPSA) and is the CEO of New Objective, Inc, an industry leader in high performance nano/microflow technologies.

FOREWORD

PREFACE

CONTRIBUTORS

1.            Patient Centric Healthcare - What's Stopping Us?

Jenny Royle and Rachel Jones

2.            Tips for Successful Quantitative Assay Development Using Mitra Blood Sampling with Volumetric Absorptive Microsampling

James Rudge

3.            Pre-analytical Considerations for Implementation of Microsampling Solutions

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

4.            Collection and Bioanalysis of Quantitative Microsamples: Technology Innovations and Practical Implications

Regina V Olivera, Marc Yves Chalom, and Carlos Roberto V. Kiffer

5.            Automation in Microsampling: at your Fingertips?

Sigrid Deprez, Liesl Heughebaert, Nick Verougstraete, Veronique Stove, Alain G. Verstraete, and Christophe P. Stove

6.            Over 50 Years of Population-Based Dried Blood Spot Sampling of Newborns; Assuring Quality Testing and Lessons Learned

Amy M Gaviglio, Kristina Mercer, Kostas Petritis, Carla Cuthbert, and Suzanne K. Cordovado

7.            Considerations for Implementation of Microsampling in Pediatric Clinical Research and Patient Care

Ganesh S. Moorthy, Christina Vedar, and Athena F. Zuppa

8.            Simplification of Home Urine Sampling for Measurement of 2,8-Dihydroxyadenine in Patients with Adenine Phosphoribosyltransferase Deficiency

Unnur A. Thorsteinsdottir, Hrafnhildur L. Runolfsdottir, Vidar O. Edvardssona, Runolfur Palssona, and Margret Thorsteinsdottir

9.            Utilization of Patient Centric Sampling in Clinical Blood Sample Collection and Protein Biomarker Analysis

Jinming Xing, Joseph Loureiro, Dmitri Mikhailov, Arkady I Gusev

10.          Enabling Patient Centric Sampling Through Partnership: A Case Study

Christopher Bailey, Cecilia Arfvidsson, Stephanie Cape, Paul Severin, Silvia Alonso Rodriguez, Robert Nelson, and Cathy Albrecht

11.          Perspectives on Adopting Patient-Centric Sampling for Pediatric Trials

Enaksha Wickremsinhe

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