Pharmacokinetic (PK) studies are usually conducted in the early stages of the drug discovery process. The data collected from these studies is used to evaluate the bio-availability and target specificity of the compound. This data helps in determining if the compound is a good candidate to move forward with larger studies. PK studies can also play a role in determining the best route of administration for the compound. Whether your compound is alone, cassette dosing, or a delivery platform, BTS Research has a core competency in performing these studies following established SOP’s. The study can be conducted under GLP per customer request.
In a typical PK study, blood samples are obtained from test animals following a single dose or a timed perfusion. Plasma or serum samples are separated and analyzed by LC/MS/MS and ELISA. Typically, if the drug is going to be administered orally, both an IV and an oral PK should be run. From these two studies both the bio-availability and the pharmacokinetics of the drug can be calculated. The data is also used to generate concentration vs. time curves and allows the determination of fundamental PK parameters such as Cmax, Tmax, AUC, drug clearance, terminal elimination half-life, oral bioavailability and volume of distribution.
Pharmacodynamic (PD) studies will help you correlate PK and show that the drug is acting on its target. We can help you determine the biomarkers to look for. Early PD studies are very important to ensure your drug candidate has sufficient potential
ADME Studies (Cold & Radioactive)
A – Absorption:
Before a compound can exert a pharmacological effect in tissues, it has to be taken in to the bloodstream. Uptake into the target organs or cells needs to be ensured. Absorption critically determines the compound’s bio-availability.
D – Distribution:
The compound needs to be carried to its effector site, most often via the bloodstream. From there, the compound may distribute into tissues and organs, usually to differing extents.
M – Metabolism:
Compounds begin to be broken down as soon as they enter the body. The majority of small-molecule drug metabolism is carried out in the liver by redox enzymes, termed cytochrome P450 enzymes. As metabolism occurs, the initial (parent) compound is converted to new compounds called metabolites. When metabolites are pharmacologically inert, metabolism deactivates the administered drug, reducing the effects on the body. Metabolites may also be pharmacologically active, sometimes more so than the parent drug. BTS Research offers bile duct capabilities in various species, radioactive “hot” and cold.
E – Excretion:
Compounds and their metabolites are removed from the body via excretion, usually through the kidneys (urine) or in the feces. Unless excretion is complete, accumulation of foreign substances can adversely affect normal metabolism.
BTS Research has a core competency in performing these studies following established SOP’s. The study can be conducted under GLP per customer request.
Continuous / Timed Drug Infusion
Infusion devices are used for continuous and precise drug administration. The drug is typically released into the blood stream at a low infusion rate. These studies are typically sub-chronic toxicity studies where the compound needs to be introduced to the animal at a number of time points during a single day. BTS Research has a core competency in performing these studies following established SOP’s. The study can be conducted under GLP per customer request.