PD Assay: Pharmacodynamic Biomarkers
PD assessments in early drug development studies can provide vital information on biological effects to help the design of later clinical studies to improve treatment. PD biomarkers are used in preclinical and clinical studies for establishing dosing regimens and therapeutic efficacy.
Accelerate drug development with safety and efficacy in mind.
The methods used to monitor the PD effects of compounds must be appropriate for the endpoints being measured and must be reliable and reproducible. PD biomarker assessments provide critical data to help you make informed, early go/no-go decisions, to select rational combinations of targeted agents, and to optimize schedules of combination drug regimens.
Rely on our team of experts for your PD assessment.
Our scientific team brings extensive expertise across a range of assays, including those for measuring soluble biomarkers, cellular phenotyping, and molecular events that ensure reliable and reproducible results.
- We are industry-leading biomarker experts using innovative platforms and a science-driven commitment to quality.
- We understand regulatory expectations for biomarker analytical validations based on the context of use.
- We have successfully developed, optimized, and validated numerous biomarker assays under various regulatory conditions, including GCLP, CLIA, as well as assays under non-regulated use.
Extensive experience with advanced platforms to evaluate PD behavior.
We help you select the best-fit platform based upon the analyte, matrix of interest, and intended use of the data, as well as the necessary sensitivity and other regulatory requirements. We are experts in developing and validating assays to evaluate PD behavior throughout all phases of the drug development process using the following platforms: