Duration of webinar : 60 Mins | Duration of Q/A session : 10-15 mins
Deliverables : Copy of presentation slides will be shared |
This webinar will present a lecture and allow a discussion on the power of stability studies to determine the properties of products in such a way that it can serve as a fingerprint of the molecule and the pharmaceutical form, not only to support shelf life. This can be particularly valuable in a comparability exercise of a medicine or a biologic. The current stability guidances of the US and EU concern medicine, generic ones or New NCEs/NMEs and not biologics.
The many guidances/guidelines of FDA, EMA, and ICH will be surveyed and international alignment, and even harmonization, will be addressed.
This presentation will cover the following areas :
- Importance of complete characterisation of drug substance & product prior to conducting stability
- Value of stability in establishing proof of comparability
- Diversity of EU and US, also ICH, written guidances and interpretation
- Shelf-life and in-use stability
- Role of stability in comparability campaigns
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Best Regards.
Marketing.
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