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An Integrated Strategy for Implementation of Dried Blood Spots in Clinical Development Programs
Prajakti A Kothare1, Kevin P Bateman2, Marissa Dockendorf3
1Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co., Inc., 770 Sumneytown Pike, West Point, Pennsylvania, 19486, USA. prajakti_kothare@merck.com.
The AAPS Journal
|February 10, 2016
Summary
Dried blood spot (DBS) sampling offers a viable alternative to plasma for pharmacokinetic studies. Merck successfully implemented DBS in late-stage clinical trials, gaining regulatory approval for its use as the sole matrix.
Area of Science:
- Pharmacokinetics and Drug Development
- Bioanalytical Methodologies
- Clinical Trial Design
Background:
- Dried blood spot (DBS) sampling is emerging as a promising alternative to plasma for pharmacokinetic (PK) analysis in pharmaceutical research.
- Limited regulatory guidance and late-stage clinical trial examples exist for DBS implementation.
- Merck sought to establish DBS as a primary matrix for PK evaluations in a late-stage program.
Purpose of the Study:
- To present Merck's strategy for implementing DBS sampling in late-stage clinical trials.
- To demonstrate the feasibility and regulatory acceptance of DBS as the sole matrix for PK studies.
- To reduce the logistical burden of sample collection in vulnerable patient populations.
Main Methods:
- In vitro and bioanalytical assessments of DBS method feasibility.
- In vivo studies in healthy subjects and patients to establish a blood-plasma concentration relationship (bridging dataset).
- Descriptive and population pharmacokinetic analyses to link DBS and plasma data.
- Submission of an integrated data package to regulatory agencies (FDA, EMA).
Main Results:
- Initial in vitro and bioanalytical tests confirmed the feasibility of the DBS method.
- A robust bridging dataset was established through Phase 1 and Phase 2/3 studies.
- Pharmacokinetic conclusions were consistently drawn across the clinical program regardless of the matrix used.
- Regulatory agencies (FDA and EMA) provided concurrence on using DBS as the sole matrix for late-stage trials.
Conclusions:
- Dried blood spot sampling is a validated and regulatory-accepted matrix for pharmacokinetic evaluations in late-stage clinical trials.
- The implementation of DBS can significantly decrease the logistical burden of sample collection, particularly in specific patient populations.
- Merck's integrated approach, combining in vitro, bioanalytical, and clinical data, facilitated regulatory acceptance of DBS.
