Future Science Group

Dried Blood Spots in Bioanalysis

Bioanalysis
Available August & November 2010

Guest Editors: Dr Neil Spooner, GlaxoSmithKline, Stevenage, UK

Dried blood spot (DBS) sampling involves spotting blood from a heel- or finger-prick onto a card which is then air dried and sealed in bags with desiccant for storage and shipping. The technique offers many advantages compared to traditional liquid blood or plasma samples including:

  • Low blood volume requirements are beneficial in pediatric studies and enable serial bleeding from one animal, so reducing the number of animals used in studies
  • Improved data quality in preclinical toxicokinetic and pharmacokinetic studies
  • Less invasive and more patient-friendly than venous cannulation
  • Cards can be stored at ambient conditions, reducing sample storage and transport costs

Although DBS has a long history of use in pediatric studies and in resource-limited settings, these advantages have generated significant current interest in DBS amongst bioanalysts, toxicologists, and pharmacokineticists who see the benefits of implementing DBS sampling in their drug development programs. Consequently, a large amount of research into the use of DBS is currently underway in pharmaceutical development laboratories worldwide.

The use of these samples can make life more difficult for the bioanalyst: smaller sample volumes have the potential to limit assay sensitivity and multiple card types and extraction solvents need to be investigated as part of method development; furthermore, the full implementation of DBS in pharmaceutical laboratories necessitates a switch from plasma to blood pharmacokinetic and toxicokinetic data; this means that both scientific and regulatory aspects will need to be considered to ensure that the use of DBS as replacement matrix for plasma in supporting drug development will meet everybody’s needs and requirements.

These two themed issues of Bioanalysis will include a mixture of review and research articles demonstrating the pharmaceutical, clinical and bioanalytical applications of DBS alongside papers illustrating advances in the surrounding technologies applicable to dried blood spot bioanalysis and commentary by internationally recognized experts.

Contents for the August Issue 2010

Foreword

  • Neil Spooner, GlaxoSmithKline

Editorial

  • Innovation sunk by Stagnation: the ever increasing need for more Validation
    Dennis Smith, Pfizer

Conference Report

  • DIA/PhRMA Workshop on Dried Blood Spot Sampling in the Pharmaceutical Industry
    Chris Evans, GlaxoSmithKline

Regulatory Focus

  • Dry Blood Spots (DBS): A UK (MHRA) Regulatory Perspective
    Michelle Beharry, MHRA

Research Articles

  • Determination of Naproxen using Dried Blood Spots (DBS): Evaluation and Pharmacokinetic Comparison of Human Plasma versus Human Blood (DBS) in Incurred Samples
    Fabio Garofolo, Algorithme Pharma Inc.
  • Performance properties of filter paper devices forwhole blood collection
    Joanne Mei, Centres for Disease Control and Prevention
  • Application of the Dried Blood Spot Methodology to a Toxicokinetic Study in Rats Including Transferability of Analysis between Bioanalytical Laboratories
    Philip Turpin, Covance
  • Dried Blood Spots Implementation within a Drug Discovery Environment: Development of a Generic Analytical Assay and its Application in Mouse PK Studies
    Graeme Clark, Pfizer
  • Can Dried Blood Spot Sampling be used to stabilize Prodrugs in Drug Discovery Rodent Studies without the addition of Esterase Inhibitors?
    Celia D’Arienzo, Bristol-Myers Squibb
  • Assessment of Dried Blood-Spot Technology for the Detection of Therapeutic Antibodies
    Peter Prince, Amgen
  • Impact of various factors on radioactivity distribution in different DBS papers
    Gary Emmons, Sanofi Aventis
  • Determination of mycophenolic acid and mycophenolic acid glucuronide in human plasma, plasma ultrafiltrate, whole blood, dried blood spots and dried plasma spots by liquid chromatography tandem mass spectrometry with on-line solid-phase extraction
    Katja Heining, F. Hoffmann-La Roche Ltd.
  • Exploring the Feasibility of Using Dried Blood Spot (DBS) Technique for Metabolite Radioprofiling
    Gary Emmons, Sanofi Aventis
  • The effect of hematocrit on assay bias when using dried blood spots samples for the quantitative bioanalysis of drugs
    Phil Dennif and Neil Spooner, GlaxoSmithKline
  • A study to assess the effect of age on control human and animal blood when used in bioanalytical DBS methods
    Paul Abu-Rabie, GlaxoSmithKline
  • The use of dry blood spot sample collection technique for the determination of circulating drug concentrations in clinical trials: Practicalities and considerations
    Neil Spooner, GlaxoSmithKline
  • Evaluating and Defining Sample Preparation Procedures for Dried Blood Spot LC-MS/MS Assays
    Guowen Liu, Bristol-Myers Squibb
  • Dried Blood Spot Sampling in Combination with LC-MS/MS for Enantioselective determination of Metoprolol and its Active Metabolite O-Desmethyl Metoprolol
    Xiaorong Liang, Covance
  • Application of Dried Blood Spots for the Quantitative Assessment of Biopharmaceuticals
    Jon Kehler, GlaxoSmithKline

The issue is available to purchase in either print or electronic format for GB£195 - to order your copy click here.