EMA: New product-specific draft guidances published [BE/BA News]

posted by mmw – India, 2018-06-29 09:20 (2563 d 19:30 ago) – Posting: # 18993
Views: 6,021

Dear All,

EMA published new product specific draft guidances for public consultation.
  1. Draft aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance
  2. Draft octreotide acetate depot powder and solvent for suspension for injection 10 mg, 20 mg or 30 mg product-specific bioequivalence guidance
  3. Draft lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance
  4. Draft apixaban film-coated tablet 2.5 and 5 mg product-specific bioequivalence guidance
  5. Draft gefitinib film-coated tablet 250 mg product-specific bioequivalence guidance

Regards,

MMW

Edit: Links added; end of consultation 30 September 2018. [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,427 posts in 4,929 threads, 1,677 registered users;
29 visitors (0 registered, 29 guests [including 12 identified bots]).
Forum time: 04:50 CEST (Europe/Vienna)

Many people tend to look at programming styles and languages like religions:
if you belong to one, you cannot belong to others.
But this analogy is another fallacy.    Niklaus Wirth

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5