zeynep
☆    

Turkey,
2019-10-24 12:22
(400 d 12:32 ago)

Posting: # 20718
Views: 2,301
 

 standby and retention samples [Regulatives / Guidelines]

Hello,

What will be the number of standby samples in a Bioequivalence study?
or what will be the percentage of standby samples to the total sample size?

Thank you,
Best Regards,
Zeynep
Ohlbe
★★★

France,
2019-10-24 13:34
(400 d 11:19 ago)

@ zeynep
Posting: # 20719
Views: 2,141
 

 standby and retention samples

Dear Zeynep,

» What will be the number of standby samples in a Bioequivalence study?
» or what will be the percentage of standby samples to the total sample size?

1. What do you call "standby samples" ?
2. For which authority / region ?

Regards
Ohlbe
zeynep
☆    

Turkey,
2019-10-24 14:21
(400 d 10:32 ago)

@ Ohlbe
Posting: # 20720
Views: 2,110
 

 standby and retention samples

» 1. What do you call "standby samples" ?
» 2. For which authority / region ?

Dear Ohlbe,

Standby samples are the reserve samples.
I am asking for TR MOH but we follow primarily EMA and/or FDA guidelines.

Best Regards


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]
Helmut
★★★
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Homepage
Vienna, Austria,
2019-10-24 14:32
(400 d 10:22 ago)

@ zeynep
Posting: # 20721
Views: 2,087
 

 Reserve samples?

Merhaba Zeynep,

» Standby samples are the reserve samples.

Still not clear what you mean by that. Once you dosed a subject, you have to analyze the samples.

Dif-tor heh smusma 🖖
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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ElMaestro
★★★

Belgium?,
2019-10-24 14:38
(400 d 10:15 ago)

@ Helmut
Posting: # 20722
Views: 2,088
 

 Spare subjects?

Hi all



» » Standby samples are the reserve samples.
»
» Still not clear what you mean by that. Once you dosed a subject, you have to analyze the samples.

I am not qualified as a mind reader, but I think what was meant was something like spare subjects / standby subjects?

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.
Ohlbe
★★★

France,
2019-10-24 17:59
(400 d 06:54 ago)

@ ElMaestro
Posting: # 20723
Views: 2,044
 

 Spare subjects?

Dear ElMAestro,

» I am not qualified as a mind reader, but I think what was meant was something like spare subjects / standby subjects?

Dunno, as retention samples (in the initial title of the thread) is the FDA terminology for investigational products (test article in FDA-speak) to be kept at the site after the trial.

Regards
Ohlbe
jag009
★★★

NJ,
2019-10-24 19:39
(400 d 05:14 ago)

@ ElMaestro
Posting: # 20724
Views: 2,073
 

 Spare subjects?

Hi El,

» I am not qualified as a mind reader, but I think what was meant was something like spare subjects / standby subjects?

Dont tell me he has samples from standby subjects :confused:
Ajit Thorat
☆    

India,
2019-10-30 11:31
(394 d 12:23 ago)

@ zeynep
Posting: # 20733
Views: 1,949
 

 standby and retention samples

» Standby samples are the reserve samples.
» I am asking for TR MOH but we follow primarily EMA and/or FDA guidelines.

Dear zeynep

For USFDA: Retention samples (Investigational medicinal product Test & Reference)
The quantity of reserve samples should be sufficient to permit the Agency to perform five times all of the release tests required in the application or supplemental application.For solid oral dosage forms (e.g., tablets, capsules), an upper limit of 300 units each for the test article and reference standard can be considered sufficient to meet the five times quantity.

Thanks

Ajit Thorat


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]
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