E-DRUG: Suggestion for industry stability studies
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It would greatly aid logistics and storage costs, and reduce waste if
pharmaceutical manufacturers front-ended their long-term at label claim
stability studies with a four to six month storage period at 40°C or 45°C
to accommodate possible shipping and storage transit temperature
excursions.
Thomas Layloff
Technical Advisor
MSH
laylofft@gmail.com
E-DRUG: Suggestion for industry stability studies (2)
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Rather then, to simulate that shipping/transit effect I would suggest that the protocol is changed to incorporate in Y1 of the RT study stepping the temperature conditions up to 40C for one month and subsequent follow the product to 36 months at the standard 30/75.
Pascal verhoeven
Pharmacist MPH
At MOH/GF Laos
Pascal <verhoeven.pascal@gmail.com>