Using In-Vitro Dissolution to Support Post Approval Changes Global Regulatory Expectations

05th February 2019 | 10:00 am EST | Xin Bu, Principal Scientist at Bristol-Myers Squibb |WATCH FOR FREE

Dissolution is one of the critical quality attributes for solid oral dosage forms, typically tablets and capsules. In addition as a quality control (QC) test to release commercial products, dissolution is often used as a comparative test to 1) apply biowaiver for lower strength(s) when multiple strengths of one product with the same or similar formulation are marketed, or 2) support post-approval changes. In these cases, in-vitro dissolution test is used in place of in-vivo bioequivalence study to establish equivalency between products of different strengths or pre- and post-change. Guidances provided by major regulatory agencies, the United States Food & Drug Administration (US FDA) and the European Medicines Evaluation Agency (EU EMEA) are often followed by many countries around the world. However, some countries/ regions, such as Australia, Japan, China, Taiwan and Korea have their own country-specific guidance. The dissolution requirements by the FDA and EMEA are generally similar and depend on the type and level of changes as outlined in the relevant guidance. The requirements from other mentioned countries are often significantly different from that of US and EU and different from each other. For products marketed globally, it’s prudent to understand the differences amongst the different country requirements when applying post-approval changes using dissolution to demonstrate equivalency. Several sets of comparative dissolution studies may have to be conducted in order to satisfy all regulatory agencies. This presentation compares differences in dissolution testing requirements among the listed countries and provide examples to illustrate how for conduct studies to comply with the relevant guidance(s).


Presented by Xin Bu, Principal Scientist at Bristol-Myers Squibb

Xin Bu is an associate director of Global Regulatory Science Department at Bristol-Myers Squibb Company. She has more than 20 years of experiences in pharmaceutical development and regulatory affair. During her tenure in pharmaceutical development, Dr. Bu led several IND development projects by leading integrated CMC teams to advance development candidates from pre-clinical to Phase II. She also led numerous analytical teams to support projects from pre-clinical to commercialization, including two successfully marked products, Reyataz and Daklinza. She has extensive experiences in project management, analytical method development and validation, and technology transfer. She is an expert in using dissolution methods to demonstrate bioequivalence and applying waiver for solid dosage forms. In her current role as Regulatory Affair Scientist, Dr. Bu is responsible for setting regulatory CMC strategy and managing investigational and marketing applications as well as post approval submissions. Dr. Bu holds a B.S. degree from Peking University and a Ph.D. in analytical chemistry from the University of Washington.


We will not sell your information to a third party. See our Privacy Policy