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Speaker Interview with Xiaoxia Ye

Performing safety assessments of parenteral drug products

Ahead of her upcoming presentation at E&L China 2019, we spoke to Xiaoxia Ye, CTO of Kun Pharmaceutical Technology, to get her insights into future significant changes in the Chinese E&L industry, the biggest challenges facing the industry, plus a sneak preview of what she'll be talking about at the event.

You will be speaking on How to perform safety assessment of parenteral drug products via appropriate experimental design – exhaustive extraction vs. simulation extraction. Can you give us a brief insight into what areas you covering in your speech?

While exhaustive extraction gives comprehensive information of the material itself, changes to the extractables due to long time storage and interactions with the drug products are not considered, and massive data generated by exhaustive extraction requires excessive analysis efforts. Therefore, it is more practical to perform simulation extraction, which requires appropriate experimental design based on the contact conditions between drug products and their contacting materials, such as liquid/solid or solid/solid contact, sterilization parameters, contact temperature and duration, drug solution properties, etc. In some cases, the combination of these two strategies gives better evaluation of the drug products. This presentation will illustrate general considerations of extractable experimental design for parenteral drug products via the comparison of data generated by exhaustive extraction, simulation extraction and leachable studies.

In your opinion, what is the #1 takeaway of your presentation?

Comparison of exhaustive extraction, simulation extraction and leachable results.

What do you see as the most significant changes coming up in the E&L regulations in China in the next 12-24 months?

Publish revised and modernized guidance for packaging materials (e.g. CHP).

Publish revised and modernized guidance for medical devices.

What are the biggest challenges that you see across the sector?

Uncertainty within the regulatory authorities regarding the experimental strategies, such as extraction conditions, AET calculation and how to choose target leachables.

Why do you feel it’s important for companies to attend E&L China 2019?

Be aware of the most updated concepts in the E&L area.

Who are you most looking forward to at E&L China 2019?

Dennis Jenke and Daniel Norwood.