Avanefil Development and Testing
Vanton established and validated the stability testing methods for Avanafil commercial product known as Stendra® (in US) and Spedra® (in Europe). The work includes:
- ICH GMP storage
- Set up stability program including QA/QC/Management
- Physical description/Assay/dissolution/Purity
- Hardness/Water Content/Microbial (USP<61>)
- Transfer methods to an European testing lab for EU market
- Develop an ODT dosage form
