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RegisterLLOQ/2 for BQLs not suggested [PK / PD]
posted by Helmut 
– Vienna, Austria, 2015-06-08 14:35 (4031 d 03:34 ago) – Posting: # 14925
Views: 11,855
Dear all,
just found an interesting statement in an EPAR of 2013:
just found an interesting statement in an EPAR of 2013:
The CHMP raised questions about the appropriateness of calculations using below limit of quantitation (BLQ) and exclusion of data. The applicant provided re-evaluated PK parameters and statistical analysis not replacing BLQ with the half value of lower limit of quantitation (LLOQ).
(my emphasis)—
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:
- LLOQ/2 for BQLs not suggestedHelmut 2015-06-08 12:35 [PK / PD]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Zero suggested? d_labes 2015-06-08 13:31
- Interpolate? Helmut 2015-06-08 14:02
- Impute? ElMaestro 2015-06-08 14:37
- "embedded BLOQ" aka "triangular points" d_labes 2015-06-08 14:51
- Interpolate? Helmut 2015-06-08 14:02
- Zero suggested? d_labes 2015-06-08 13:31
Ing. Helmut Schütz