Microsampling Strategies for Early-Phase Drug Development

United Pharmaceuticals offers advanced microsampling solutions designed to support modern preclinical and early clinical drug development programs. By enabling reliable bioanalysis from very small blood volumes, microsampling reduces subject burden while delivering high-quality pharmacokinetic, toxicokinetic, and biomarker data.

Our scientists have developed optimized microsampling workflows that integrate sample collection, bioanalysis, and data interpretation—allowing sponsors to generate robust results while improving study efficiency, compliance, and translational value. Microsampling services can be implemented as standalone bioanalytical support or fully integrated into broader development programs.

 

Role of Microsampling in Bioanalytical Studies

Microsampling enables precise bioanalysis using minimal biological material, making it particularly valuable for early-phase studies where frequent sampling, ethical considerations, or limited sample volume are critical factors.

 

Supported Sample Matrices

• Whole blood (capillary and venous)
• Plasma and serum derived from low-volume collections
• Alternative biological fluids, such as saliva or urine, when appropriate to study objectives

 

Microsampling Collection Technologies

United Pharmaceuticals applies validated microsampling techniques selected based on study design, analyte characteristics, and regulatory expectations.

 

Commonly Used Microsampling Methods

• Dried Blood Spot Sampling
  Controlled blood deposition onto absorbent media enables simplified storage, transport, and long-term stability without reliance on cold-chain logistics.
   
• Volumetric Absorptive Microsampling (VAMS®)
  Enables accurate and reproducible volume collection, improving quantitative performance and reducing variability in pharmacokinetic and biomarker studies.
   
• Capillary-Based Sampling
  Utilizes microcapillary devices to collect small blood volumes with minimal invasiveness, eliminating the need for traditional venipuncture in certain populations.

 

Applications in Biomarker and Translational Research

Microsampling plays a critical role in biomarker-driven development strategies by enabling frequent, low-burden sample collection across large or vulnerable populations.

Key applications include:

• Biomarker discovery and validation in preclinical and clinical studies
• Longitudinal monitoring in chronic dosing or population-based trials
• Enhanced exposure–response and pharmacokinetic–pharmacodynamic correlations

 

Integrated Bioanalytical Workflows

Our microsampling services are supported by purpose-built bioanalytical workflows designed to ensure accuracy, reproducibility, and regulatory compliance.

Capabilities include:

• Dedicated sample storage and tracking systems supporting incurred sample reanalysis (ISR) in line with regulatory guidance
• Ultra-high-performance liquid chromatography combined with triple quadrupole mass spectrometry for high sensitivity and selectivity
• Optimized extraction methodologies to ensure consistent and unbiased analyte recovery from microsampling substrates
• Validated workflows supporting both small-molecule and large-molecule analysis

 

Advantages of Microsampling Across Development Stages

Preclinical Benefits

• Minimizes stress and physiological impact on research animals
• Enables serial sampling from the same subject, improving data quality
• Eliminates the need for satellite animal groups
• Enhances correlation between exposure and toxicological findings

 

Clinical Benefits

• Significantly reduces blood volume requirements
• Enables pharmacokinetic studies in pediatric, geriatric, or needle-sensitive populations
• Supports decentralized and remote sampling models
• Allows more frequent sampling to enrich pharmacokinetic datasets

 

Bioanalytical Benefits

• Reduces challenges related to plasma handling, storage, and transport
• Improves analyte stability in dried matrices for certain compound classes
• Accelerates method development and sample throughput
• Lowers overall operational complexity and cost

 

Advancing Smarter, Patient-Centric Development

Microsampling represents a shift toward more efficient, ethical, and patient-friendly study designs. By combining advanced sampling techniques with robust bioanalytical expertise, United Pharmaceuticals helps sponsors generate high-quality data while reducing risk and accelerating early development decisions.