Microsampling for quantitative bioanalysis, an industry update: output from an AAPS/EBF survey
Shefali R Patel1, Peter Bryan2, Neil Spooner3
1DMPK Department, Discovery Sciences, Janssen Research & Development, LLC, 1400 McKean Road, Springhouse, PA 19477, USA.
Bioanalysis
|April 12, 2019
Summary
Microsampling technologies are increasingly used in drug development, especially for nonclinical studies. Dried blood microsampling is preferred for clinical applications, enabling challenging sample collection and richer data.
Area of Science:
- Drug development
- Bioanalytical sciences
- Pharmacokinetics
Background:
- Growing interest in microsampling technologies for drug development.
- Microsampling offers potential benefits for sample collection and data acquisition.
- Industry-wide adoption is increasing but not yet universal.
Purpose of the Study:
- To survey current practices and adoption trends of microsampling technologies.
- To understand the extent of microsampling implementation across different study types.
- To identify preferred microsampling methods in clinical settings.
Main Methods:
- Survey conducted among members of the AAPS bioanalytical community microsampling subgroup and the European Bioanalysis Forum.
- Responses gathered from 39 individual organizations.
- Analysis of current practices and adoption rates of microsampling.
Main Results:
- Microsampling implementation is becoming increasingly common, particularly in nonclinical studies.
- A notable number of organizations have submitted microsampling data in regulatory filings.
- Dried blood microsampling is the predominant approach for clinical studies.
Conclusions:
- Microsampling technologies are gaining traction in drug development, with varied adoption rates.
- Nonclinical and non-regulatory studies show higher microsampling adoption.
- Dried blood microsampling is favored in clinical settings for feasibility and data richness.
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