Bioequivalence and Bioavailability Forum • EMA: Q&A Update

EMA: Q&A Update [BE/BA News]

posted by luvblooms – India, 2013-11-16 07:36 (3811 d 03:34 ago) – Posting: # 11896
Views: 28,631

Dear All

Yesterday EMEA has also published first set of product-specific bioequivalence guidance similar to that of FDA.
In the first set BE guidance of following products has been updated

Capecitabine
Carglumic acid
Dasatinib
Emtricitabine/tenofovir disoproxil
Erlotinib
Imatinib
Memantine
Miglustat
Oseltamivir
Posaconazole
Repaglinide
Sirolimus
Sorafenib
Tadalafil
Telithromycine
Voriconazole

Details of specific guidances could be found at this link http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000370.jsp&mid=WC0b01ac0580032ec5.

—
~A happy Soul~

Complete thread:

EMA: Q&A Update Helmut 2013-11-15 13:53
- EMA: Q&A Updateluvblooms 2013-11-16 06:36
  - The early bird gets the worm Helmut 2013-11-16 12:20
    - The early bird gets the worm but luvblooms 2013-11-16 14:23
      - Lambda Therapeutic Ltd.? Helmut 2013-11-16 15:25
        
        Lambda Therapeutic Ltd.? luvblooms 2013-11-16 19:24
- EMA: Q&A Update; Expected studies for Quetiapine PR Tablets viveksraut 2018-08-06 14:42