The dissolution test is a primary quality control test that all products must pass to be on the market. With evolving dosage form types, the dissolution test—or some may call the technology the in vitro release test—is constantly being improved or changed with newer equipment and methodology. Setting appropriate specifications for the test is a challenge for industry and regulatory agencies. Harmonization of the dissolution test is an ongoing point of discussion, as is the calibration of the equipment. The in vitro and in vivo correlation (IVIVC) is still a centerpiece for many discussions as to the ability of the test to predict bioequivalence.
The purpose of this focus group is to provide a forum for discussion across industry, regulatory agencies, and academia for development of useful and standardized methods to meet the challenges of new dosage forms and to improve or encourage innovation of new methodologies, provide a more in-depth understanding of IVIVC, and encourage discussion of topics of interest.
Goals and Objectives
- Explore new technologies/equipment for in vitro release testing of novel dosage forms.
- Explore in vitro release testing methods for dosage forms other than solid oral dosage forms.
- Identify current method development problems and the associated dosage forms.
- Discussion of validation principles for new and standard methods.
- Explore how the test may be more relevant to the human physiology.
- Provide a forum for discussing the process for setting specifications.
- Explore the use of dissolution testing in applying the BCS/biowaivers.
- Discuss the calibration parameters of all official apparatus.
- Harmonization of ICH and Pharmacopeias
- Statistics and modeling related to in vitro release and dissolution testing.
Section affiliation: APQ | FDD | RS