Bioequivalence and Bioavailability Forum

Requirement of temperature data before dosing [Study Per­for­mance]

posted by ElMaestro  – Denmark, 2017-07-20 14:13 (2904 d 18:24 ago) – Posting: # 17575
Views: 7,574

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.

Complete thread:

• Requirement of temperature data before dosing anky1212 2017-07-20 08:08 [Study Per­for­mance] 
  • Requirement of temperature data before dosing Ohlbe 2017-07-20 09:57
    • Requirement of temperature data before dosing anky1212 2017-07-20 10:21
      • Requirement of temperature data before dosing Ohlbe 2017-07-20 10:24
        • Requirement of temperature data before dosing anky1212 2017-07-20 11:33
          • Requirement of temperature data before dosingElMaestro 2017-07-20 12:13