Dissolution/in vitro drug release focus group

Our mission

The quality of pharmaceuticals is still of great concern to FIP and the World Health Organization. The dissolution test has emerged as a most powerful tool to assess the product quality of a drug and its in vivo performance.
We are involved in enhancing the science in the field of dissolution. We also include novel/special dosage forms in our focus.

Our goals for 2018 are to:

  • Publish a FIP dissolution guideline on solid oral dosage forms.
  • Identify proposals for symposia for the FIP annual conference, Abu Dhabi, UAE, 2019.

Who we are

The Focus Group on Dissolution/In Vitro Drug Release is chaired by Dr Horst-Dieter Friedel (Bayer, Germany)). Current group members include Cynthia K. Brown, Amy R. Barker, Vinod P Shah, Johannes Krämer, J. Michael Morris, Christos Reppas, Lucinda Buhse, Susanne Keitel, Mary P Stickelmeyer, Margaret Marques, Kumiko Sakai-Kato.

Some of the focus group members at Nanomedicines
workshop: (from left: Vinod Shah, Margareth Marques,
Amy Barker, Johannes Krämer, Dieter Friedel)

What we do

Recent activities can be found in our 2017 annual report. The group publishes guidelines and papers and holds workshops.
Our publications include:

Our workshops include:

  • Biorelevant dissolution testing, Washington, USA, in 2013. (The results of the workshop were published in Pharmaceutical Research, 31:1867-76, 2014.
  • Oral Biopharmaceutics Tools: What is New and What is Coming? APV/FIP Joint-Workshop in Nuremberg , September 26-27, 2017
  • Nanomedicines The group organised, in collaboration with AAPS (American Association of Pharmaceutical Scientists) and USP (US Pharmacopeia), a three-day workshop on nanomedicines in Rockville, USA, in March 2017. Over 150 representatives from industry, academia, regulatory and pharmacopeial bodies participated. New scientific and regulatory perspectives were the focus of this workshop.
  • “Hands-on-Dissolution” Workshops Since 1999, the focus group has initiated 13 “Hands-on-dissolution” workshops in collaboration with the WHO to improve the drug product quality, especially in developing countries. The most recent was held in Bucharest, Romania, in 2016. All these workshops have been well attended and participants receive FIP certificates of attendance.

Contact

For more information on this focus group, please contact Dr Friedel at RegulatorySciences@fip.org