Microsampling for quantitative bioanalysis, an industry update: output from an AAPS/EBF survey

Bioanalysis. 2019 Apr;11(7):619-628. doi: 10.4155/bio-2019-0019. Epub 2019 Apr 11.

Abstract

There is continuing interest in the development and application of various microsampling technologies for drug development. The AAPS bioanalytical community microsampling subgroup and the European Bioanalysis Forum conducted a survey of their members (39 individual organizations). This gives a snapshot of current practices and demonstrates that implementation of microsampling approaches is becoming increasingly commonplace, but not universal. Greater adoption was observed for nonclinical studies, particularly nonregulatory. A number of respondents reported that they have included microsampling data in regulatory submissions. Another important observation was that where microsampling is employed for clinical studies, dried blood approaches predominate, reflecting the interest in their use where they enable sample collection which is not feasible with standard approaches or to derive richer data sets.

Keywords: AAPS; DBS; EBF; microsampling survey; quantitative bioanalysis.

MeSH terms

  • Animals
  • Blood Specimen Collection / methods*
  • Dried Blood Spot Testing
  • Drug Evaluation, Preclinical
  • Humans
  • Pharmaceutical Preparations / analysis*
  • Pharmaceutical Preparations / blood
  • Pharmaceutical Preparations / metabolism
  • Societies, Scientific*
  • Surveys and Questionnaires

Substances

  • Pharmaceutical Preparations