Log in
RegisterExpiry Dates of Biostudies [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2004-10-05 21:04 (7938 d 04:50 ago) – Posting: # 10
Views: 14,392
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.'
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!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Expiry Dates of BiostudiesHelmut 2004-10-05 19:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
Ing. Helmut Schütz