PK/TK Studies (GLP and Non-GLP)

Pharmacokinetic (PK) and Toxicokinetic (TK) studies are usually conducted in the early stages of the drug discovery process. Routes are often I.V. AND the proposed clinical route and conducted in rodents and non-rodents.  TK/PK studies are often single-dose, but can be repeat-dose.  The data collected from these studies are used to evaluate the bio-availability of the compound and are helpful in determining if the compound is a good candidate to move forward with larger studies, as well as determining doses for potential Phase 1 human trials. PK studies can also play a role in determining the best route of administration for the compound in animals and in potential early human trials.  Non-GLP PK/TK studies use a minimum number of animals and the data are often used to screen test articles.