Bioequivalence and Bioavailability Forum • Tadalafil: Similar technology and formulas as the originator

Tadalafil: Similar technology and formulas as the originator [BE/BA News]

posted by mmw – India, 2015-07-17 13:38 (3198 d 03:22 ago) – Posting: # 15103
Views: 14,351

Dear All,

Further, EMA published draft of product-specific draft guidance for asenapine, prasugrel, sitagliptin and zonisamide for demonstration of bioequivalence.

Please check following links

EMA/CHMP/PKWP/269533/2015
EMA/CHMP/PKWP/36761/2015
EMA/CHMP/PKWP/36869/2015
EMA/CHMP/PKWP/253507/2015

Thanks

MMW

Edit: Documents linked. [Helmut]

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 originatormmw 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

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