Expiry Dates of Biostudies [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2004-10-05 19:04  – Posting: # 10
Views: 9,288

Dear colleagues!

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.'

Cheers,
Helmut Schütz
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