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Custom Assay Development Services
Take a look at our Custom Assay Service capabilities for developing your PK/PD Assay Learn More
Pharmacokinetics and pharmacodynamics (PK/PD) studies
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 often have a limited ability to measure the low concentrations of a given drug such as those used in micro-dosing studies. Compared to traditional methods, SMC™ high sensitivity immunoassays allow for the detection of lower levels of a drug to provide a more complete PK/PD profile. Furthermore, SMC™ immunoassays allow for the identification of unpredictable clearance patterns that were previously undetectable by traditional immunoassay methodologies.
SMC™ high-sensitivity immunoassays provide new perspectives for low therapeutic index drug development.
SMC™ advantages include:
- High value PK/PD data at low doses
- Optimized therapeutic index at low doses
- Simplified workflow
- Clear understanding of safety and efficacy
- Informed Go/No-Go decisions in Phase I/II
- Reduced attrition and development cost
Due to the enhanced ultra-high sensitivity, SMC™ technology is able to detect much lower levels of a drug, ensure that relevant biology can be discovered, and micro-dosing studies can be conducted at or below the level of detection available by conventional PK methodologies
Scientific partnership and support
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).