Justification for the lack of incurred sample reanalysis [Regulatives / Guidelines]

posted by irene – Greece, 2017-02-15 08:56 (2923 d 11:10 ago) – Posting: # 17059
Views: 3,317

Dear Dr_Dan,

thank you for your answer.

Yes, the study is old, conducted in 2007, but the submission regards a RUP, and I was wondering whether the study can be accepted even though ISR is missing.

Kind regards,
Irene

Complete thread:

UA Flag
Activity
 Admin contact
23,381 posts in 4,914 threads, 1,663 registered users;
42 visitors (0 registered, 42 guests [including 14 identified bots]).
Forum time: 20:07 CET (Europe/Vienna)

Science is built up with facts, as a house is with stones.
But a collection of facts is no more a science
than a heap of stones is a house.    Henri Poincaré

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