When a client has developed a novel molecule that is going to be used to treat a human or veterinary disease, they need to know that the compound is biologically active and is absorbed, distributed, metabolized and excreted. A common challenge that our clients encounter is the disconnect between in-vitro chemistry and the in-vivo dose formulations that will be administered to a test system. Spending valuable time and money troubleshooting the formulation of a compound that doesn't yield exposure data is a detriment to the client's objective. The inability to get a go-no-go answer from a PK study can cost the client considerable time, energy and money for a product that may never make it to the target population and market.
Attentive’s way of assisting clients to overcome and solve this challenge is High Throughput PK in-vivo Screening. We will take your compound, formulate it in several vehicles (based on the type of drug and utilizing our collective experience), and will administer it directly into a test system to identify general tolerability. Better yet, we can collect blood samples and send it to our partner bioanalytical lab who can analyze the serum/plasma sample to determine if the drug is present or not, as well as provide simple minimal PK parameters. This screening is a way for the client to be able to get a quick read on if they have a druggable product.
Rather than investing a lot of time and money into the development of a single formulation for the lead candidate only to find out at the in-vivo stage you don’t have exposure or the formulation is not well tolerated – call Attentive and save both time and money. Running a High Throughput PK Formulation Screening and getting Attentive involved early will allow you to evaluate your drug candidates and provide you the necessary data to make informed decisions for the selection and advancement of your lead compound.
This is not the typical way of doing things but it is a way in which Attentive can help you save valuable time and money for your entire drug development program.