BCS-based biowaivers for Class III [Dissolution / BCS / IVIVC]

posted by The Outlaw Torn – Europe, 2018-06-21 12:11 (859 d 07:54 ago) – Posting: # 18939
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Thanks for the response. Agreed if the situation was as you described. Unfortunately, R (syrup) is discontinued. Tablets are available (API is BCS I), but we are exploring BCS-based biowavers for this product and we're also trying to get familiar with BCS-based biowaiver needs in case we want to go that route with other products too.

Not sure about the flag thing (I can't see any flags); but I requested an "Europe" designation a few years ago to remain incognito in order to be more open on BEBAC. And, yes, I actually am in Europe.

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