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

  • ICHM10 Bioanalytical method validation - overview of comments