Expiry Dates of Biostudies [Regulatives / Guidelines]
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.'
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
The quality of responses received is directly proportional to the quality of the question asked. 🚮
- Expiry Dates of BiostudiesHelmut 2004-10-05 19:04 [Regulatives / Guidelines]