You’re an early seed funded company or early venture backed biotech and you would like to expand or confirm the PK conducted by the innovator. There may have only been pharmacology or in vitro data available on your molecule and you’d like to understand if there is an exposure response relationship. What do you do? Do you seek out the large CRO BD team? Do you rely on your consultant? Do you look for a lab that can conduct the dosing and blood selection, then a lab to analyze the drug and then someone to interpret the PK data; all while you have a tight timeline? That may be three different organizations and then you still need to determine the most appropriate formulation, which may be a fourth. Depending on how this logistics nightmare plays out for you, you may decide to put off the PK study, wait in a large CRO queue or worse, scale it ‘to get something’. The last option may lead to a limited exposure dataset that is not interpretable, a disproportionate large bill and future headaches.
In addition, we’ll collect behavioral observational data that will support the general tolerability of your product. We do not just collect plasma samples for plasma pharmacokinetics. We’ll collect urine, feces, plasma and blood to fully understand drug absorption, distribution and excretion so you can be better informed in developing your research and development strategy. None of us want to see a program die but at times a well-designed rodent PK study can be very informative to program viability and subsequent strategy.
Species: Mouse and Rat
Administration Routes: IV, PO, IP, SC, Intraplantar, CSF, IM
Sample Matrixes: Plasma, Blood, Urine, Feces, Bile, CSF, CVF, Tissues
Study Designs: Complex DDI, Drug Metabolism studies to medicinal chemistry PK screens and cassette dosing
If there is a board meeting/conference deadline/go no/go decision point that is time critical then talk to us about our rapid turn-around service
We can provide data in excel, abbreviated synopsis report or full study report or work within your company’s required format.
Xyzagen can support your large animal PK studies through its 3rd party in vivo vendors. Xyzagen can transfer the rodent bioanalytical method to dog, rabbit or monkey plasma and oversee the dosing and sample collection at its vendor then run the sample analysis and pharmacokinetic interpretation within its own lab.
Modeling and simulation have become indispensable in model based drug development. However the access costs to building these models can be significant, particularly in early phase drug discovery. Xyzagen, takes a different approach in early drug discovery and development and conducts simple compartmental modeling to simulate different dosing strategies for internal drug development decision making rather than regulatory submission or clinical model based drug development. These models can also be used in regulatory meetings or with IRB’s to support scientific dose selection decision making.