Date recorded: May 26 2021
Selection of the appropriate techniques and assays, and their application in well-managed analytical programs, can simplify the process of deformulation and ensure a speedy route to market.
Whether you need an in-depth understanding of a pharmaceutical product because you are changing the supply of an ingredient, moving between manufacturing sites, or tackling the development of a new generic, you’ll likely find yourself asking:
- What needs to be assayed?
- Which techniques should be applied?
- What should our testing program look like?
In this webinar, we’ll take a stepwise journey through the foundations of deformulation (reverse engineering) and in vitro bioequivalence (IVBE) testing, providing answers to these questions and more. We’ll consider challenges including the impact of flavor changes and container modifications on bioavailability profiles, and we’ll also take a deeper dive into the Q3 bioequivalence testing requirements for specific dosage forms.