Rajinikanth.S
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India,
2024-03-20 09:41
(23 d 06:34 ago)

Posting: # 23912
Views: 412
 

 Truncated AUC [NCA / SHAM]

Dear All,

If a subject(s) misses the last sampling point or few sampling time points before the 72 hours for a Treatment(s) then the AUC0-72/48/96 etc. hours parameter will be excluded for that Treatment(s) for that subject(s). If study involves measuring multiple analytes, the concept would be applied only to relevant analyte which is responsible for truncating the sample collection to 72 hours. Whenever there is no possibility to compare both Test and Reference formulations for AUC0-72 [e.g.: the issue of missing sample(s) exists in one of the Treatment(s) only], AUC0-72 of such subject(s) will be excluded for both treatments from the pharmacokinetic analysis and this scenario is mostly applicable for two way cross-over design.

Is it reliable statement, Plz confirm.


Edit: Category changed and subject line changed; see also this post #1 and #2[Helmut]
Helmut
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Vienna, Austria,
2024-03-21 14:17
(22 d 01:58 ago)

@ Rajinikanth.S
Posting: # 23914
Views: 307
 

 Truncated AUC

Hi Rajinikanth,

❝ Is it reliable statement, Plz confirm.

First of all trunctated AUC is only acceptable for IR formulations.
Do you want to know whether your statement (in an SOP or a protocol) is acceptable to the authorities? Perhaps this presentation helps (slides 19–27).

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