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Registerτ in SD = intended dosage interval [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2016-08-26 13:08 (2794 d 02:31 ago) – Posting: # 16581
Views: 5,663
Hi BE-proff,
You are.
The MR GL again, this time with the important part in red:
Here τ is the intended dosage interval for the labeled posology. Say you want to dose b.i.d. (τ=12). In the SD study you will sample long enough to get a reliable estimate of λz (for the calculation of AUC0-∞). Now you have to show that AUC0–12 covers more than 90% of AUC0-∞ in order to waive the MD study.
❝ Unless I am mistaken,
You are.
❝ … to comply with the statement you have cited we need to conduct steady state study anyway. Otherwise, how to get AUC0-tau?
The MR GL again, this time with the important part in red:
A multiple dose study is needed unless a single dose study has been performed with the highest strength which has demonstrated that the mean AUC(0-τ) after the first dose covers more than 90% of mean AUC(0-∞) for both test and reference, and consequently a low extent of accumulation is expected.
Here τ is the intended dosage interval for the labeled posology. Say you want to dose b.i.d. (τ=12). In the SD study you will sample long enough to get a reliable estimate of λz (for the calculation of AUC0-∞). Now you have to show that AUC0–12 covers more than 90% of AUC0-∞ in order to waive the MD study.
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Helmut Schütz
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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:
- multiple dosage study Mahesh M 2016-08-18 12:50 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- multiple dosage study VStus 2016-08-24 21:37
- multiple dosage study Mahesh M 2016-08-25 09:36
- multiple dosage study VStus 2016-08-25 18:34
- multiple dosage study BE-proff 2016-08-26 10:45
- τ in SD = intended dosage intervalHelmut 2016-08-26 11:08
- multiple dosage study Mahesh M 2016-08-26 14:17
- Some questions from EGA regarding MR Guideline mittyri 2016-08-26 17:43
- Quod licet Iovi, non licet bovi Helmut 2016-08-26 19:42
- τ in SD = intended dosage intervalHelmut 2016-08-26 11:08
- multiple dosage study Mahesh M 2016-08-25 09:36
- multiple dosage study VStus 2016-08-24 21:37
Ing. Helmut Schütz