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Determination of In Vivo In Vitro Correlations (IVIVC) for Sustained Release (SR) Parenterals (Depo Formulations)
Tuesday, November 13
2:00 pm – 4:30 pm
Symposium
ACPE #073-999-07-519-L04
A key goal in pharmaceutical development of dosage forms is a good understanding of the in vitro and in vivo performance of the dosage form. One of the challenges of biopharmaceutical research is correlating in vitro drug release information to the in vivo drug profiles (IVIVC). Regulatory guidance and publicized guidelines are available. However, most of the release method development and IVIVC guidelines have focused on oral formulations (both immediate and sustained release). Several challenges exist in method development for SR parenterals and these need to be dealt with on a case-by-case basis. Even with these challenges, regulatory agencies may apply the same criteria of oral formulations to SR parenterals. This symposium will introduce challenges and illustrate current technical strategies used to achieve IVIVC for SR parenterals from industry regulatory and academic perspectives. The latest developments in in vitro release methods and IVIVC testing for SR parenterals will be discussed with case studies. Based on current situation, the roundtable should reach the following objectives: 1. Introducing the current status of IVIVC for SR Parenterals; 2. Raise major issues in the development of IVIVC determination for SR Parenterals; 3. Discuss the possible solution and seek recommendations; and 4. Pave the way to the future.
ModeratorS
Kenneth J. Norris, M.S.
Pfizer, Inc.
Jaymin C. Shah, Ph.D.
Pfizer, Inc.
In Vitro/In Vivo Correlations for Parenterals Sustained Release Formulation
Patrick Marroum, Ph.D.
U.S. Food and Drug Administration
Difficulty in Determination of IVIVC for SR Parenterals
Colm Farrell, Ph.D.
ICON Development Solutions