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John O'Neill
John ONeill Enterprises LLC
San Mateo CA 94404
United States
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Hani,
If you have the original stability studies used to justify the 6 month shelf life still in the chambers with sufficient samples remaining, I would continue those (for the duration of the trials if possible). You will want to identify an appropriate model for calculation of shelf life (some have applied Arrhenius to DES) using stability-indicating data from an accelerated condition and launch new studies utilizing lots representative of those in the Clinic with samples placed at both the long term storage condition and the accelerated condition. There is an FDA Guidance that includes stability of combination products such as DES. Continued dialogue with the FDA concerning your plans is always a priority.
Regards,
John O'Neill
Original Message:
Sent: 04-22-2014 07:58
From: Hani Rauch
Subject: Shelf life extension of DES during clinical trials
All,
We are at the begining of clinical trails for drug eluting stent systems (DES). The preliminary shelf life was set at 6 months after discussion with the FDA. We manufactured additional systems from each lot in order to perform mechnical and analytical test and extend the shelf life. How can we determain the new shelf life, assuming the tests pass their accepatnce criteria?
Thank you,
Hani
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Hani Rauch
Medinol
Tel Aviv
Israel
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