Disturbing wording [Dissolution / BCS / IVIVC]
Hi ElMaestro,
that’s not new. Same wording was already given in the FDA’s
August 2000 Guidance and the
Draft Revision 1 of May 2015. Same story in Appendix I of the EMA’s BE-GL.
that’s not new. Same wording was already given in the FDA’s
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![[image]](img/uploaded/IAsmall.png)
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:
- Disturbing wording ElMaestro 2017-12-25 18:28 [Dissolution / BCS / IVIVC]
- Disturbing wordingHelmut 2017-12-26 13:14
- Literature reported Permeability Studies Accepted? sameep 2017-12-28 11:10
- Reliable source, sufficient number of subjects Helmut 2017-12-28 12:17
- Comparative BA study vs Biowaiver for BCS I sameep 2018-01-02 09:35
- Reliable source, sufficient number of subjects Helmut 2017-12-28 12:17
- Literature reported Permeability Studies Accepted? sameep 2017-12-28 11:10
- Disturbing wordingHelmut 2017-12-26 13:14