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RegisterAUC72 [Design Issues]
posted by Helmut 
– Vienna, Austria, 2012-08-22 17:13 (5050 d 18:25 ago) – Posting: # 9093
Views: 2,329
Hi Pandu!
Are you talking about an oral suspension?
Are you referring to a product-specific guidance?
Basically yes – provided conditions in the![[image]](img/uploaded/IAsmall.png)
FDA’s guidance are applicable. For details see also this thread.
❝ We are developing suspension formulation and its half-life is 60hrs.
Are you talking about an oral suspension?
❝ USFDA OGD says that two-way crossover study.
Are you referring to a product-specific guidance?
❝ Can we truncate upto 72hrs for these studies? Is this approved by USFDA?
Basically yes – provided conditions in the
FDA’s guidance are applicable. For details see also this thread.—
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:
- Suspension design Pandu 2012-08-22 14:18
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- AUC72Helmut 2012-08-22 15:13
Ing. Helmut Schütz