Bioequivalence and Bioavailability Forum

Dear Group Members,

Why do we need to store plasma samples of bioequivalence studies below -70 degrees? Is the storage temperature stated in any of the guidelines?

Besides the stability of the drug & deactivation of enzymes in plasma, is there any other specific reason for storage below -70 degrees?

Which is the optimum temperature to be used for storage of plasma samples -60 or -70 or -80 degrees?

Some CRO's are storing samples even at -20 degrees, based on literature survey. Is this acceptable from regulatory point of view?

Thanks & regards,
Dr. Harish L. Rao