AGENDA
Topics BioBridges 2019
- ICH M9 - BCS Guideline - overview of comments/final version
- EMA Scientific Advices
- Draft guideline on quality and equivalence of topical products
- Well established use procedures
- Product specific BE guidelines
- Dissolution for specific products, vaginal rings, suspensions, IVIVC
- ICH M10 Bioanalytical Method Validation - overview of comments
Institute of Pharmacology | First Faculty of Medicine | Charles University in Prague | Albertov 4, 128 00 Prague 2 | Czech Republic