Wow, what a gem! [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2014-02-10 18:15 (3719 d 19:31 ago) – Posting: # 12384
Views: 19,333

Hi Shuanghe,

❝ This gonna be a really lengthy post […]. I had the impression that administrators don't like the lengthy post but at least I didn't find such prohibition from forum policy :-)


My own posts have a strong tendency to be verbose as well… The limit in the database is currently set to 15,000 characters. Yours has 10,131 including blanks. So there is still some head room.

THX for the codes!

Edit 2014-07-30: I expect something in the near future from EMA (in the Q&A?). See:
CHMP, Agenda of the 21-24 July 2014 meeting, page 23:

CMDh request to PKWP on acceptability of Mahalanobis test for proof of comparable dissolution (bio­waiver) for additional strengths of a bio-batch strength

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