IMP handling [Regulatives / Guidelines]

posted by mittyri – Russia, 2017-05-09 01:40 (2623 d 01:17 ago) – Posting: # 17328
Views: 29,887

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

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