Vanton developed the formulation and secured a world-wide patent right for the client. It is currently in Phase 3.
The work includes:
- Feasibility study/Formulation development
- GLP manufacturing and management
- CTM prep (Phase I) and trial distribution (double blind)
- Prepare IND document (CMC section)
- Develop testing methods and run stability program
- CTM prep (Phase II) and trial distribution (double blind)