Bioequivalence and Bioavailability Forum

auditor
★

India,
2010-08-30 14:22
(5762 d 06:27 ago)

Posting: # 5866
Views: 4,610

Abrent Value [Bioanalytics]

Dear Sir,

Kindly advice on below mentioned case:

We have done one study containing parent drug and it's active metabolite. During reveiwing the data, it is observed that abrent concentration observed in metabolite profile however parent drug shows no abrent concetration (parent drug concentration is BLQ up to first three time point whereas in metabolite one abrent concentration observed between two above LLOQ concntration). In this case is it necessary to analyzed metabolite under "Abrent Concntration code"? Kindly advice on that. With regard to this i would like to clear that we have same analytical method with diffrent Calibration Curve range for parent drug and it's metabolite.

Regards,

Auditor

Jaime_R ★★ Barcelona, 2010-08-30 15:01 (5762 d 05:48 ago) (edited on 2010-08-30 18:33) @ auditor Posting: # 5867 Views: 3,824	Abrent? Post reply
	Hi Auditor! Macmillan Dictionary, Merriam-Webster... Lots of stuff: concentration, concetration, concntration,... — Regards, Jaime

keshav khude
☆

2010-08-31 09:36
(5761 d 11:13 ago)

(edited on 2010-08-31 10:04)
@ auditor
Posting: # 5869
Views: 3,917

Abrent Value

Post reply

Dear Auditor,

In repeat analysis under aberrant value is always a ???. For this till no accepted guidelines or suggestions to be published for analysis of repeat under aberrant value.

In your case, I suggest,

If you're analytical method is simultaneous, and only one analyte showing aberrant value and remaining is not identified, so it was not be consider as a aberrant value because your sample collection and analysis procedure is same for both the analyte.
The aberrant value observed in initial two time point which concentration is near to your LOQ QC, so it not to be aberrant, at lower concentration these may happen due to revesible/irrevsible metabolism by CYP process in Parent to Metabolite conversion .
For Aberrant value identification, required to define procedure in the internal Repeat SOP, with considering appropriate criteria to compare of aberrant value with respect to its two adjacent Preceding and succeeding value in a similar way.

Regards,

Keshav D.Khude

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! Please check the spelling of your messages before posting them - your post is rather difficult to comprehend; see also this post. [Jaime]

Abrent Value [Bioanalytics]

Abrent?

Abrent Value