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Fields & Applications Pharma & Biopharma

How to stop good pharmaceutical formulations going bad: a study in controlling behaviour

sponsored by Malvern Panalytical

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Wednesday, May 26, 2021. 14:00 BST

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 flavour 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.

Webinar Learning Objectives:

  • 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, flavouring 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.

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