My first question concerns HOLDING TIME:
Are there any guidelines specifying how stability studies for bulk
products i.e. granulate, cores, film-coated tablets should be
designed and performed? I mean testing period, temperature and
humidity range? Do you have any personal experiences with performing
such experiments?
My second question concerns:
MEAN KINETIC TEMPERATURE
Is it possible to predict, how storage of bulk product in bin for
some period of time or transport conditions, influence drug product
shelf life\its stability? Do we have to perform any specific
stability experiments? Is it acceptable to use a known data set
(results obtained at ACC, LT conditions) to infer information about
future data? Is it acceptable to use statistics for calculating
allowed Holding Time or influence of transport conditions on drug
product shelf life?
Can we use for such calculation: Arrhenius equation and this way
predict influence on above mentioned factors on drug product
stability and its shelf life? Is this proceed acceptable from
regulatory point of view?
I am waiting for your advices.
Kind Regards
Aleksandra
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Aleksandra
aleksandra.zaborska@neostrada.pl
Pharmaceutical Company
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