The situation
Three prototypes, a preclinical PK study on each, and a decision due before the tox batch is committed.
What we do
- Rank on in vivo exposure, not dissolution alone
- Separate real differences from study noise
- Build and test the dissolution-to-exposure correlation
What you get
- A ranked recommendation, with the reasoning
- Dissolution specifications backed by exposure
- A first correlation to carry into clinical development
Regulatory basis
For extended-release oral products, FDA guidance allows an IVIVC established on human data to support a biowaiver when formulation, process or site change. Ranking prototypes on in vivo exposure early prepares the ground for it.