(6740 d 05:55 ago)
Posting: # 10
Although it may be not a good idea to use 'old' studies for a regulatory submission – since scientific progress may be pretty fast – the only national guideline mentioning an 'Expiry Date' for a BA/BE study comes from South Africa, which states at 3.10 (page 13):
'The bioavailability/bioequivalence study should have been completed not longer than five years prior to the date of submission.'
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