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RegisterFormulation-dependent [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2017-10-30 11:42 (1974 d 12:26 ago) – Posting: # 17949
Views: 3,003
Hi Anand,
That’s not possible. Discriminatory in vitro conditions depend on the properties of formulations. You have to develop ones which are discriminatory for your product.
❝ Kindly suggest Discriminatory Dissolution media for Atorvastatin & Rosuvastatin.
That’s not possible. Discriminatory in vitro conditions depend on the properties of formulations. You have to develop ones which are discriminatory for your product.
- Produce a target batch (expected to be BE to the reference) and two side batches (expected to fail on the lower and upper end).
- Perform a small 3-way in vivo study.
- Find in vitro conditions which discriminate between batches. Ideally full IVIVC or at least matching rank order.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Discriminatory Dissolution Media Anand 2017-10-30 06:50 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Formulation-dependentHelmut 2017-10-30 10:42
Ing. Helmut Schütz