Log in
RegisterULOQ [Study Assessment]
posted by Helmut 
– Vienna, Austria, 2017-10-30 11:30 (2695 d 04:57 ago) – Posting: # 17947
Views: 8,714
Hi Anand,
Perform a partial validation with a higher dilution. If passing the usual criteria for A&P, re-analyse the sample(s) with high concentrations.
IMHO, that’s not possible.
❝ In our Pivotal BE Study ULOQ was observed, whether we should exclude from PK?
❝ After Dilution also it found ULOQ.
❝ Method should be redeveloped or revalidated?
Perform a partial validation with a higher dilution. If passing the usual criteria for A&P, re-analyse the sample(s) with high concentrations.
❝ If included,What justification we should provide to Regulatory Agency?
IMHO, that’s not possible.
—
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:
- ULOQ Anand 2017-10-30 06:38 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ULOQHelmut 2017-10-30 10:30
- ULOQ Ohlbe 2017-10-30 10:35
- ULOQ Helmut 2017-10-30 10:59
- ULOQ Ohlbe 2017-10-30 15:10
- Not excluding invalid data? Helmut 2017-10-30 17:34
- Excluding invalid data Ohlbe 2017-10-30 18:03
- Not excluding invalid data? Helmut 2017-10-30 17:34
- ULOQ Ohlbe 2017-10-30 15:10
- ULOQ Helmut 2017-10-30 10:59
- ULOQ ElMaestro 2017-10-30 13:18
- Serial dilutions? Don’t! Helmut 2017-10-30 17:53
Ing. Helmut Schütz