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Pharmacokinetics

End-to-end PK assay support from preclinical to clinical development

Bioanalytical services are one of the cornerstones of drug development, providing the critical data needed to understand a compound’s pharmacokinetic (PK) profile—how it is absorbed, distributed, metabolised, and excreted in the body. 

 

These insights are essential for determining dosing strategies, evaluating safety and efficacy, and supporting regulatory submissions. ICON brings extensive experience in the development and execution of PK assays for a broad spectrum of drug modalities such as small molecule drugs, monoclonal antibodies, bi- and trispecific antibodies, antibody-drug conjugates (ADCs, fab fragments, oligonucleotides (e.g., siRNA, antisense). Moreover, we support both preclinical and clinical studies, ensuring continuity and scientific rigor throughout the development lifecycle.

To meet the diverse analytical needs of these modalities, we employ a wide array of cutting-edge technologies:

  • LC-MS/MS (Liquid Chromatography–Tandem Mass Spectrometry): The gold standard for small molecule quantification, offering high sensitivity and specificity across a range of biological matrices.
  • Ligand Binding Assays (LBAs): Ideal for large molecule therapeutics, including:
    • ELISA – widely used for protein quantification.
    • ECLIA – electrochemiluminescence-based assays with enhanced sensitivity.
    • SMCxPRO – single molecule counting technology for ultra-sensitive detection of low-abundance analytes.
  • PCR (Polymerase Chain Reaction): Applied for nucleic acid-based therapeutics, including qPCR and digital PCR for precise quantification.
  • Flow Cytometry: Used for cell-based PK assessments.

All assays are developed and validated in compliance with global regulatory guidelines (e.g., FDA, EMA, ICH), ensuring data quality, reproducibility, and regulatory readiness. Our scientists work closely with sponsors to design fit-for-purpose assays that align with study objectives and therapeutic strategies.

By combining deep scientific expertise with advanced technologies and a commitment to quality, ICON’s bioanalytical solutions deliver reliable data that drives informed decision making and accelerate drug development.

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