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Stability studies: Understand the most common problems and optimize protocols


 

Moderator A3P : Pierre ANDRE
facilitators: Emmanuel BILLA - Cébiphar & Manuella MARTIN-JOUET - Ethypharm


After a reminder of the technical and regulatory bases linked to stability studies, the workshop will concentrate on the most frequently encountered concrete problems (and still not covered by the guidelines) for which the feedback from industry and specialized providers is paramount. The workshop will allow participants to have a global and precise vision of the implementation of stability studies on both the active ingredients and the finished products.

After a targeted review of various problems encountered (bulk products, transport, variations, sampling, impurities, etc.), the participants work in subgroups on specific cases:

- Establish a standard protocol
- Optimize protocol (notions bracketing / matrixing)
- Develop a stability protocol in use (in use stability)
- Interpreting the data and establish stability lapses and conservation recommendations

Restitution of cases studied by different groups concluded the workshop and led to the development of a synthesis of the various current approaches to stability studies.

This workshop is for anyone involved in the implementation or outsourcing stability studies for active ingredients and medications pre and post marketing authorization.

Consult the full program of the Congress // View A3P Congress program

 

 

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