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

posted by mmw – India, 2018-06-29 07:20 (886 d 02:29 ago) – Posting: # 18993
Views: 3,476

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:

Activity
 Admin contact
21,224 posts in 4,427 threads, 1,481 registered users;
online 9 (0 registered, 9 guests [including 2 identified bots]).
Forum time: Tuesday 08:50 CET (Europe/Vienna)

The fundamental cause of trouble in the world today is
that the stupid are cocksure
while the intelligent are full of doubt.    Bertrand Russell

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