Pharmacokinetics (PK) / Pharmacodynamics (PD) Assessments

Premier Preclinical And Clinical Support For PK/PD Assay Development And Validation

In addition to PK assays, the analysis of pharmacodynamic (PD) markers is a central aspect to study the biochemical and biological effects of drugs and the mechanisms of their actions, including the correlation of their actions and effects with their chemical structure.

Pharmacodynamic (PD) markers monitor biological effects used in decision making in early drug development. PD markers are used in pre-clinical and clinical studies for establishing doses and dosing regimen for future studies.

Often PD markers are generic but the assays have to be validated for their intended purpose. Some PD markers are regulated upon treatment, e.g. neopterin and 2′-5′-OAS upon interferon treatment, but often these markers are also regulated by non-drug induced events and have a limited values. The search for specific PD markers is challenging and in the focus of many research groups.

The analytical spectrum for the detection of PD markers is broad and comprises molecular techniques such as quantitative real-time RT-PCR and immunological techniques such as ELISA, ECL, CLIA, RIA and others.

BioAgilytix’s Expertise in PD Markers

We combine deep, industry-leading PD expertise with innovative platforms and a science-driven commitment to quality to help support even the most complex PD studies. Our scientific team will help provide the creativity, customization, and responsiveness to help improve efficiencies as well as PK/PD project outcomes.

Let us help you bring clarity to the complexities of pharmacodynamics.

PK Analysis: An Essential Step in the
Drug Development Process

Pharmacokinetics (PK) describes what the human body does to a given pharmaceutical, from the time of administration to absorption, distribution, metabolism, and excretion from the body. By assessing PK of a biological drug in different samples, including serum, plasma, urine, and saliva, we can understand a drug’s interaction with the body, as well as the intensity and duration of its efficacy.
Pharmacodynamics (PD) studies the biochemical, physiologic, and molecular effects of drugs on the body and involves receptor binding, postreceptor effects, and chemical interactions. Together PK/PD data explain the dose-response relationship of a drug and are integral in designing the dose, route, and schedule of administration to maximize effectiveness while reducing adverse effect
Understanding the pharmacokinetic and pharmacodynamic behavior of a given therapeutic drug is an essential element of understanding its effectiveness and safety, as well as identifying the proper dosage and distribution. PK assay bioanalytical testing methods are used to determine concentration time profiles of the drug and metabolites in biological sample fluids, providing information necessary for PK analysis. PK assays are a vital component of the drug development process, and the data derived is used to help select dosage for preclinical and clinical studies. The Federal Drug Administration (FDA) has also issued extensive industry guidance on measuring Population Pharmacokinetics (PK).

Optimal Platforms for Pharmacokinetic Assays: Ensuring Reproducible Results

There are several analytical technologies that can be used for PK analysis and to assess PD profiles. BioAgilytix will help you select the best-fit platform for your project, based on both sensitivity and regulatory requirements. We have extensive experience developing and validating assays to evaluate pharmacokinetic and pharmacodynamic behavior throughout the phases of the drug development process using the platforms listed below.





Flow Cytometry (FACS Analysis)