Is there a role for microsampling in antibiotic pharmacokinetic studies?

Area of Science:

• Pharmacokinetics
• Clinical Pharmacology
• Analytical Chemistry

Background:

• Clinical pharmacokinetic studies are crucial for optimizing antibiotic dosing regimens.
• Microsampling techniques enable less-invasive sample collection, potentially improving patient compliance and accessibility.
• Innovations in microsampling offer advantages for challenging patient populations.

Purpose of the Study:

• To review microsampling methods applicable to antibiotic pharmacokinetic studies.
• To identify challenges hindering the implementation of microsampling in clinical settings.
• To propose a framework for assessing the suitability of microsampling.

Main Methods:

• Overview of various microsampling techniques: dried blood/plasma spots, volumetric absorptive microsampling, capillary microsampling, plasma preparation technologies, and solid-phase microextraction.
• Discussion of implementation challenges: study design, regulatory acceptance, and bioanalytical validation.
• Presentation of a conceptual framework for suitability assessment.

Main Results:

• Available analytical technology for microsampling is underutilized.
• Lack of bridging studies and validated bioanalytical methods are significant impediments.
• A contingency approach is proposed for assessing microsampling suitability.

Conclusions:

• Addressing validation deficiencies is critical for microsampling adoption in antibiotic pharmacokinetics.
• The proposed conceptual framework guides the assessment of microsampling suitability.
• Implementation requires consideration of antibiotic properties, patient factors, and robust bioanalytical validation.