The PK Lab operates on a fee-for-service model providing bioanalytical services, data modeling, and drug stability studies. Drugs and their derivatives, such as metabolites, are assayed in biological matrices, such as blood, plasma, serum, urine, saliva and cerebral spinal fluid. Aqueous solutions are also assayed for shelf and stress stability studies of compounded pediatric preparations. The current library of analytical methods and respective standard operating procedures (SOPs) is continually expanded with the development and validation of new methods as new projects are being initiated or contracted.
The PK Lab facilities house a Liquid Chromotograpghy/Mass Spectometry ( LC/MS) and a Gas Chromotograpghy/Mass Spectometry (GC/MS) systems, as well as Untraviolet (UV) plate reader for enzymatic assays. Operating under standard Good Laboratory Practices (GLP) the PK Lab includes two laboratory rooms each with roughly 150 square feet, separate office and storage spaces, and deep freezing storage in a dedicated freezers bay.
The PK Lab licenses state-of-the-art pharmacometrics software which is validated to process and analyze all kinds of data. Either from clinical samples assayed in the lab or from numerical data supplied by the client, comprehensive modeling and simulations are conducted and reported as per current regulatory guidance.
Current drug assays include :