Bert
☆    

Netherlands,
2019-01-24 14:14
(675 d 09:18 ago)

Posting: # 19804
Views: 2,127
 

 random calibration samples [Bioanalytics]

Is there any guidance for the location of calibration samples in an analytical run? Should this be at-random? (Like it, called Junior :-) )

Thx for your input, Bert
ElMaestro
★★★

Belgium?,
2019-01-24 17:11
(675 d 06:22 ago)

@ Bert
Posting: # 19805
Views: 1,847
 

 random calibration samples

Hello Bert,

» Is there any guidance for the location of calibration samples in an analytical run? Should this be at-random? (Like it, called Junior :-) )

There is to the best of my knowledge no guidance that deals explicitly with it.
Sometimes such samples are in the beginning of a run, and often the outcome is monitored so that if something is clearly out of whack the run can be terminated early so as not to lose PK sample material.
Some CROs with rock-solid systems intersperse them rather randomly throughout runs after a few sys suit injections. Others yet have two sets of cals per run, one in the beginning and one in the end.

All variants seem to work fine in terms of regulatory acceptance.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2019-02-02 15:49
(666 d 07:44 ago)

@ Bert
Posting: # 19846
Views: 1,602
 

 No random calibrators (and QCs)

Hi Bert,

» Is there any guidance for the location of calibration samples in an analytical run?

Not that I recall. I agree with ElMaestro’s comments.

» Should this be at-random?

Not a good idea – even if there is no substantial carry-over (see the EMA’s GL Section 4.2.2). If you decide to inject calibrators at the start and end of the batch do so with increasing concentrations which minimizes the relative impact of carry-over. If you have calibrators within the set of unknown samples inject a blank after. The same is applicable for QC samples as well.

» (Like it, called Junior :-) )

Not referring to your age or experience but the number of posts in the forum. :-D
Junior : <25
Regular: 25 < 100
Senior : 100 < 500
Hero   : >500

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Bert
☆    

Netherlands,
2019-02-04 08:20
(664 d 15:12 ago)

@ Helmut
Posting: # 19854
Views: 1,634
 

 No random calibrators (and QCs)

» Junior : <25
» Regular: 25 < 100
» Senior : 100 < 500
» Hero   : >500

Thx Helmut and ElMaestro Already wondered why you call yourself a hero :-)


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
Activity
 Admin contact
21,220 posts in 4,427 threads, 1,481 registered users;
online 18 (0 registered, 18 guests [including 13 identified bots]).
Forum time: Sunday 23:33 CET (Europe/Vienna)

Half the harm that is done in this world
Is due to people who want to feel important.    T. S. Eliot

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5