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.'
The quality of responses received is directly proportional to the quality of the question asked. ☼