High-sensitivity immunoassays are critical in pharmacokinetics (PK) and pharmacodynamics (PD) studies to measure low concentrations of drugs. Explore this review of high-sensitivity immunoassays in PK/PD studies to see different case studies showing how ultrasensitive immunoassay technology is used for PK/PD profiling.
Traditional methodologies offer limited capacity for PK/PD profiling and are often unable to show the full clearance profile of some drugs. In addition, they have limited ability to measure the low concentrations of a given drug such as used in micro-dosing studies. High-sensitivity immunoassays have allowed for the detection of lower levels of a drug to provide a more complete PK/PD profile. They also allow for the identification of unpredictable clearance patterns that are undetectable by traditional immunoassay methodologies.
Single Molecule Counting (SMC™) high-sensitivity immunoassay products and services for PK/PD studies accelerate pharmaceutical, clinical, and life science research. The patented SMCxPRO™ immunoassay system is an innovative digital technology that measures single molecules at femtogram per mL concentrations. Using this platform, a broad range of ultrasensitive immunoassays enable the measurement of baseline biomarker concentrations in healthy subjects and differentiation of response to therapy.
See how high-sensitivity SMC™ immunoassays were used for PK/PD profiling in these case studies.
Figure 1.Pharmacokinetic graphs showing SMC™ assays have a lower LLOQ than ELISAs.
Figure 2.The pharmacokinetics of cTnI in the Wistar Han rat was analyzed with a two-compartment model. 300 μL rat blood samples were collected at multiple time points and measured for cTnI. Open circles are serum cTnI concentrations from individual animals.
Figure 3.The pharmacokinetics of cTnI in the beagle dog were analyzed with a two-compartment model. Open circles are serum cTnI concentrations from individual animals. Each data line tracks the serum cTnI concentration from the same dog post-dosing. Values are reported as means and SDs.
SMC™ high-definition ultrasensitive immunoassays provide new perspectives for low therapeutic index drug development.
Benefits of this ultrasensitivity include:
Figure 4.Ultrasensitive measurement enables you to detect small differences in the minimum effective concentration and minimum toxic concentration of a drug with a narrow therapeutic index.
The SMC™ ultrasensitive immunoassay platform can detect much lower levels of drug ensuring that relevant biology can be discovered. This is important for micro-dosing studies since they can be below the level of detection by conventional PK methodologies (Figure 5).
Figure 5.Example of a micro-dosing study showing the need for a lower level of detection to get the full PK profile. Work completed at Singulex® Inc., Alameda, California. 2013.
With years of extensive experience sample testing, our in-house SMC™ custom assay development group can assist you in your immunogenicity assay development, including cut point analysis, customer ADA sample testing, PK/PD analysis, and full kit manufacture (ISO 9001).
Learn more about our comprehensive portfolio of homebrew kits and reagents for developing the assay that suits your specific drug-development application.