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/ real time and stress/accelerated stability studies to document beyond use date (BUD) information for 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. All work is compliant with Title 21 of the Federal Code of Regulations for Laboratorial Good Practices.
The PK Lab facilities house a state-of-the-art Liquid Chromotograpghy/Mass Spectometry system (UPLC/MS/MS), as well as Untraviolet (UV) plate reader for enzymatic assays and many other ancillary laboratory equiptment. 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 different 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 :