IMP handling [Regulatives / Guidelines]

posted by mittyri – Russia, 2017-05-09 01:40 (2840 d 16:31 ago) – Posting: # 17328
Views: 30,942

Hi Helmut,

I suppose the problem could be not in the case of 'significant separation in time' but in case of some mistakes in IMP handling.
For example, RIMP has a proven stability up to 30C and TIMP up to 25 only. Due to some "why bother" attitude the designated employee missed it. As a result the second group will be treated with poor TIMP. I assume here that the order of groups treatment is
GR1PER1
GR1PER2
GR2PER1
GR2PER2
The CRO's are usually mixing the time for groups for more effective time management.

So I think in case of appropriate IMP handling we wouldn't observe any real (not false-positive) interaction.
Please correct me if I'm wrong here.

Kind regards,
Mittyri

Complete thread:

UA Flag
Activity
 Admin contact
23,381 posts in 4,914 threads, 1,663 registered users;
46 visitors (0 registered, 46 guests [including 7 identified bots]).
Forum time: 17:12 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