Bioequivalence and Bioavailability Forum • Premethod validation of x drug

Jagdish Bairagi
☆

2010-07-27 18:34
(5047 d 02:08 ago)

Posting: # 5694
Views: 2,700

Premethod validation of x drug [Bioanalytics]

Hello all
we had done the validation of x drug ,But during study sample ,AFTER COMPLETION analysis of four subject, it was found that the concentration obtain from subject samples do not cover not two quality control samples , maximum conCENTRATION obtain in subject was 2000 ng/ml and our QC IS 50 NG/ML, 2100NG/ML AND 4000NG/ML .IS THAT POSSIBLE TO ADD one more additinal QC sample below the C MAX obtained in sample profile.and is that to do the partial validation with this additinal QC,AND IN PARTIAL VALIDATION which experiment i can do ,isthat 3 P&A BATCH IS SUFFICIENT FOR PARTIAL VALIDATION

Edit: Category changed. [Helmut]

Helmut
★★★

Vienna, Austria,
2010-07-27 18:45
(5047 d 01:57 ago)

@ Jagdish Bairagi
Posting: # 5696
Views: 2,303

Gibberish

Post reply

Dear Jagdish,

please read this post first - and don't use all capital letters (which is interpreted as shouting on the web)!
I'm not willing to decrypt your Gibberish. :not really:

You have all the time in the world to set up your text in a readable form before posting (use the Preview-button!). Please edit your post within the next 24 hours. Otherwise your chances of getting an answer are pretty low.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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keshav khude
☆

2010-08-13 12:08
(5030 d 08:34 ago)

@ Jagdish Bairagi
Posting: # 5779
Views: 2,108

Premethod validation of x drug

Post reply

Dear All,
First you can observe the concentration profile of minimum 20 % of the whole study samples/subjects,then you decide to add for one more QC as a LMQC (concentration between LQC and MQC). For this not required to perform 3 P &A batch or partial validation, only perform bulk spiking check for LMQC and continue analysis with added QC.

Thanks,

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! [Ohlbe]