Bioequivalence and Bioavailability Forum • EMA: 7 product-specific guidances adopted

EMA: 7 product-specific guidances adopted [BE/BA News]

posted by Helmut – Vienna, Austria, 2015-07-07 16:10 (3213 d 16:54 ago) – Posting: # 15048
Views: 17,283

Dear all,

today the EMA published a new batch of product specific guidances (capecitabine, sirolimus, sorafenib, sunitinib, tadalafil, telithromycin, and voriconazole). The guidances were adopted by the CHMP on 21 May 2015 and will come into effect on 1 December 2015.
The “Compilation of individual product-specific guidance on demonstration of bioequivalence” Rev. 2 gives in its new Annex C as the effective date 1 November 2015. Lacking QA?

Links to all documents here.

—
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:

EMA: 7 product-specific guidances adoptedHelmut 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 published Helmut 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