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.
発表者
- Caroline German - Technical Director, Concept Life Sciences
- Paul Senior - Team Leader, Method Development & Validation, Concept Life Sciences
- Paul Kippax - Sector Director, Pharmaceuticals, Malvern Panalytical
詳細
What will I learn?
- Understand the regulatory requirements for reverse engineering or deformulation of a pharmaceutical product, and the techniques employed to achieve this and establish bioequivalence.
- Find out how even the smallest changes such as an alteration to packaging, flavoring or product size might impact the performance of the final product.
- See how you can expect analytical techniques to be applied and reverse engineering programs to be run within a contract research organization setting.
Who should attend?
Senior/Principal Scientists and analysts, lab managers, department heads and regulatory affairs managers and directors involved in the development and manufacture of both innovator and generic small molecule drugs. Particularly those with an interest in topics including deformulation (reverse engineering) and bioequivalence testing (including in vitro bioequivalence – IVBE).