Application of dissolution testing to regulatory approval in EU
- At: 2009 FIP Congress in Istanbul (Turkey)
- Type: Presentation
- By: BARENDS, Dirk (RIVM, Bilthoven, Netherlands)
The European Pharmacopoeia only contains a general chapter on dissolution testing, no monographs on specific drug products. So, in the EU, pharmaceutical companies are free to propose the release dissolution method for their drug product, taking into account scientific soundness. For drug products containing new drug substances, the dissolution.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.