Are you having difficulty interpreting your Tox data, and are you not seeing linear responses? Are you certain you have a consistent API form, as well as particle attributes with the appropriate vehicle?
Variability in crystal form and amorphous content, in addition to varying particle size/surface area, can render your PK studies meaningless, and lead to their needing to be repeated all while you give it your “best guess”. This can be expensive… Understanding the physicochemical characteristics of your API is and what happens to it in PK studies, can help eliminate unnecessary variability in your animal studies.
In addition, baseline screening and understanding will lead to a robust API isolation process that reproducibly gives you the right form, and with the right particle size, at the highest possible yield. The benefits of working with VxP are the following:
- We are a One-stop shop utilizing solid-state and biopharmaceutical properties
- in design from candidate selection through early development
- We utilize an Integrated approach to find the right form and formulation
- We offer the shortest timeline for appropriate development milestones
- We provide you with an optimized route to achieve exposure, eliminate unnecessary experiments and enable pre-clinical studies
Pharma companies large and small have found that a small amount of solid-state work can both accelerate and strengthen your development program, as well as your IP. We can make your preclinical formulation development, as well as your API manufacturing, the best it can be.
Some of the services we can provide:
- Rapid, Partial, and Complete solid state chemistry phase screenings
- Characterization of physiochemical properties of your API
- Formulation development and Optimization for your preclinical dosing studies
- API Isolation: Form control, Particle attribution control, ee Upgrade
Please let us know if your availability for a 30 minute FREE consultation with our team.