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