LLOQ/2 for BQLs not suggested [PK / PD]

posted by Helmut Homepage – Vienna, Austria, 2015-06-08 14:35 (3216 d 02:53 ago) – Posting: # 14925
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Dear all,

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)

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