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Microsampling: considerations for its use in pharmaceutical drug discovery and development.

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Microsampling techniques offer ethical advantages and enable novel sample collection in drug development. These methods are crucial for quantitating analyte concentrations in biological samples from various studies.

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Area of Science:

  • Pharmacology and Drug Development
  • Bioanalytical Chemistry
  • Clinical Research

Background:

  • Growing interest in microsampling for quantifying circulating analyte concentrations in biological samples.
  • Ethical benefits of reduced blood volumes, especially in rodent, pediatric, and critical care studies.
  • Facilitation of sampling in challenging locations and situations, enabling additional sample collection.

Purpose of the Study:

  • To provide a comprehensive overview of microsampling utilization in drug discovery and development.
  • To offer recommendations for best practices in nonclinical, clinical, and bioanalytical aspects of microsampling.
  • To highlight the advantages and expanded applications of microsampling technologies.

Main Methods:

  • Review of current microsampling technologies and their application in drug development.
  • Analysis of ethical considerations and practical benefits of reduced sample volumes.
  • Exploration of novel sampling opportunities and additional data acquisition.

Main Results:

  • Microsampling enhances ethical considerations by minimizing blood volume requirements.
  • Enables sample collection from previously inaccessible sites and during critical events.
  • Facilitates collection of additional samples for further analyses, such as biomarkers.

Conclusions:

  • Microsampling approaches are increasingly valuable in drug discovery and development.
  • Recommendations for best practices are provided for nonclinical, clinical, and bioanalytical applications.
  • These methods offer significant advantages for ethical and efficient biological sample analysis.