Optimizing a PK assay for reliable data

12 April 2024

Pharmacokinetic (PK) assays play a crucial role in quantifying biopharmaceuticals, biomarkers, and immunogenicity, guiding critical decisions in drug development and ensuring the reliability of obtained data. Mercodia discusses the re-optimization of a pharmacokinetic assay, highlighting improvements made to enhance reliability, precision, and efficiency. Key changes include minimizing false positives, implementing urgent and long-term solutions for non-specific responses, and addressing edge effects in plate assays. The re-optimized assay underwent validation and was successfully utilized in phase 1 and phase 2 clinical studies, demonstrating its effectiveness in providing reliable data for drug development.