Requirement of temperature data before dosing [Study Per­for­mance]

posted by ElMaestro  – Belgium?, 2017-07-20 12:13 (1092 d 04:21 ago) – Posting: # 17575
Views: 4,995

Hi anky1212,

» Storage condition is to store product between 15-30 degree centrigrade

If you are not sure the IMP was stored within the storage recommendation interval, or that any deviations do not affect the quality (/safety/efficacy) then you should probably not dose any subjects with it. Storage conditions exist for a reason.

Quarantine the IMP, contact the sponsor to get a statement from the release office or QP. All this is likely a part of your QMS already.:-)

I could be wrong, but...

Best regards,
ElMaestro

"Pass or fail" (D. Potvin et al., 2008)

Complete thread:

Activity
 Admin contact
20,859 posts in 4,361 threads, 1,451 registered users;
online 17 (1 registered, 16 guests [including 8 identified bots]).
Forum time: 16:34 CEST (Europe/Vienna)

The interpretation of facts in a certain way
stimulates other scientists’ thoughts.    Róbert Bárány

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