This session was held on February 23, 2022 and featured three speakers (James Polli, Sandra Suarez-Sharp and Thomas Hoffelder). The focus was on the challenges and issues in meeting regulatory requirements for in vitro dissolution testing.
The f2 parameter in dissolution testing of solid oral dose products is a standard tool for assessing similarity of dissolution profiles for obtaining biowaivers in an ANDA and under SUPAC. To conclude that two dissolution curves are similar, the value for f2 must be between 50 and 100. FDA restricts the use of the standard calculation of the f2 parameter to situations where the relative standard deviation (RSD) is not more than 20% at the earlier time points and not more than 10% at other time points. Although the FDA recommends alternative methods when high variability exists, how to use these methods and interpret the results is often unclear. This is especially true considering FDA’s evolving position on dissolution profile comparisons.
Via this webinar, we wanted to fill the gap in understanding the various methods being advocated by FDA to evaluate similarity of dissolution profiles and how to apply these methods.