Date: 21 May, Tuesday
Time: 1 - 1:45 p.m. (Malaysia & Singapore) | 10:30 - 11:15 a.m. (India) | 3 - 3:45 p.m. (Australia)
Presenters: Dr Tausif Ahmed and Sivacharan Kollipara
Location: Zoom Live Webinar
Registration: Free for JMP users and non-users
Navigating regulatory landscapes with case studies
Comparing dissolution profiles is vital in pharmaceutical development. Dissolution similarity assessment is crucial for supportng various regulatory aspects, including biowaivers, site transfers, SUPAC changes, and sameness testing. Traditionally, the f2 similarity factor has been the go-to for assessing similarity. However, with highly variable dissolution profiles, more complex statistical analyses are necessary, leading to a surge in regulatory queries in this area.
In this webinar, we delve into regulatory expectations surrounding similarity testing for highly variable dissolution profiles. Specifically, we cover bias corrected and accelerated f2 concepts, as well as demonstrate data analysis using JMP through real-life case examples. Join us as we simplify the complexities of dissolution profile comparison and provide useful insights for navigating regulatory requirements effectively.
Recommended level: Beginner to intermediate