Bioequivalence and Bioavailability Forum • Five new drafts published

Five new drafts published [BE/BA News]

posted by Helmut – Vienna, Austria, 2016-08-23 17:09 (2795 d 19:26 ago) – Posting: # 16563
Views: 11,797

Dear all,

on 01 August the EMA published a new batch of product specific guidances for comment:

End of consultation is 31 October 2016.

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Complete thread:

EMA: 7 product-specific guidances adopted Helmut 2015-07-07 14:10
- EMA: 7 product-specific guidances adopted mittyri 2015-07-08 13:55
  - capecitabine ≠ NTID; reference-scaling Helmut 2015-07-08 14:59
- Tadalafil: Similar technology and formulas as the originator luvblooms 2015-07-10 07:24
  - Tadalafil: Similar technology and formulas as the originator mmw 2015-07-17 11:38
- 9 new just published Ohlbe 2016-04-07 19:08
- Five new drafts publishedHelmut 2016-08-23 15:09
  - New product specific guidance of Fidaxomicin Mahesh M 2016-08-24 05:58
- EMA: 7 product-specific guidances adopted (Capecitabine) Mauricio Sampaio 2016-12-12 19:33
  - Capecitabine: study with healthy volunteers mittyri 2016-12-14 12:39

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