Pharmacokinetic ELISA
The Pharmacokinetic (PK) ELISA is a highly sensitive and specific assay used to measure the concentration of therapeutic drugs, especially monoclonal antibodies, peptides, or small molecules, in biological samples such as serum or plasma. This ELISA is essential for understanding the absorption, distribution, metabolism, and excretion (ADME) of a therapeutic agent, thereby supporting drug development, dosing optimization, and regulatory compliance.
Content
- Purpose:
- Quantifies the drug concentration in biological matrices to evaluate its pharmacokinetic profile.
- Detects free or total drug levels depending on the assay design.
- Mechanism:
- Utilizes specific capture antibodies or antigens immobilized on a solid-phase support.
- A detection antibody conjugated to an enzyme (e.g., HRP) binds to the drug in the sample.
- The enzymatic reaction produces a measurable signal proportional to the drug concentration.
Applications
- Drug Development:
- Supports preclinical and clinical studies by characterizing drug exposure over time.
- Bioequivalence Studies:
- Compares pharmacokinetic profiles of biosimilars or generic formulations with reference products.
- Immunogenicity Assessment:
- Distinguishes drug concentrations in the presence of anti-drug antibodies (ADAs).
- Toxicology Studies:
- Correlates drug levels with potential toxicity during safety evaluations.
The Pharmacokinetic ELISA is a cornerstone tool for drug discovery and development, providing critical data for optimizing therapeutic efficacy and ensuring patient safety.
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