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RegisterEMA: No AUC(0-72h) for all MR products [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2023-10-18 09:09 (54 d 01:45 ago) – Posting: # 23764
Views: 744
Hi JP2030,
❝ Please share your opinion on Delayed-Release Tablets can we use study design AUC truncated at 72 h (AUC(0-72h)) for EU Submission? It's acceptable.
❝ Terminal Elimination Half-Life (T1/2el) of the drug is 67 hrs.
A truncated AUC(0-72h) is not acceptable for MR products.
On page 26:Single dose: AUC(0-t), AUC(0-∞), Cmax
Scientifically this does not make sense for DR products…—
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:
- Delayed Release Formulation -AUC truncated at 72 h (AUC(0-72h)) JP2030 2023-10-18 05:58 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: No AUC(0-72h) for all MR productsHelmut 2023-10-18 07:09
Ing. Helmut Schütz