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

posted by mmw – India, 2018-06-29 07:20 (1131 d 17:21 ago) – Posting: # 18993
Views: 4,028

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
21,606 posts in 4,517 threads, 1,532 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Wednesday 00:41 CEST (Europe/Vienna)

Scientists cannot simply hang their subjectivities
up on a hook outside the laboratory door.    Ruth Bleier

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