shreyas goswami
☆    

India,
2024-06-01 13:13
(17 d 03:25 ago)

Posting: # 24013
Views: 818
 

 Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission [Bioanalytics]

Dear Members,

As per text stated in "Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies" for Health Canada," If a subject withdraws from the study for personal reasons or because of non-compliance with the protocol (e.g., positive drug test) before completing at least two periods of the study, the subject’s blood samples do not have to be analysed."

What can be the consequences if drop out subjects due to personal reason or protocol non-compliance are been analyzed during bioanalytical stage.

Can regulatory agency raise a query???? or any plausible significances occurs which leads to impact the study results.

Kindly, share your opinions.


Thanks in advance:-).

Shreyas Goswami.
Ohlbe
★★★

France,
2024-06-03 11:13
(15 d 05:26 ago)

@ shreyas goswami
Posting: # 24017
Views: 658
 

 Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission

Dear Shreyas,

❝ What can be the consequences if drop out subjects due to personal reason or protocol non-compliance are been analyzed during bioanalytical stage.


The guidance says that you do not have to analyse them, not that you should not analyse them. They're just trying to spare you some time and money. If you have already spent them, well, too bad for you, but I don't see why they would care.

Regards
Ohlbe
shreyas goswami
☆    

India,
2024-06-03 19:15
(14 d 21:23 ago)

@ Ohlbe
Posting: # 24018
Views: 624
 

 Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission

Dear Ohlbe,

Thank you for the clarification:-)

Can agency think like something done fishy?????

As drop out subjects will not be considered for statistical calculations, then why did the analysis been performed for drop out subjects?

Regards,
Shreyas Goswami.
qualityassurance
☆    

2024-06-04 07:25
(14 d 09:13 ago)

@ shreyas goswami
Posting: # 24019
Views: 612
 

 Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission

Dear Shreyas,

What your study protocol and SOP says? If it is deviation from your SOP and protocol, file the deviation, take proper CAPA. I think this is suffice.

If final outcome of the study does not change with and without this subject, it does not seems any risk.

Regards,
QA
Helmut
★★★
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Vienna, Austria,
2024-06-05 13:33
(13 d 03:05 ago)

@ qualityassurance
Posting: # 24021
Views: 517
 

 All samples might be informative

Hi QA and Shreyas,

❝ What your study protocol and SOP says? If it is deviation from your SOP and protocol, file the deviation, take proper CAPA. I think this is suffice.

I agree.

❝ If final outcome of the study does not change with and without this subject, it does not seems any risk.

I would not perform two analyses for BE, only report the concentrations of the subject who withdraw consent. See the footnote of this post why in my CRO we analyzed all samples.

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Ohlbe
★★★

France,
2024-06-04 11:54
(14 d 04:44 ago)

@ shreyas goswami
Posting: # 24020
Views: 572
 

 Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission

Dear Shreyas,

❝ Can agency think like something done fishy?????


Well, with Agencies you never know, some people tend to be paranoid, but they have grown good reasons to be over the last years. However I would not be too worried.

❝ As drop out subjects will not be considered for statistical calculations, then why did the analysis been performed for drop out subjects?


Well, with ICH M10 you have to submit all chromatograms from all runs. They will easily be able to check that you only analysed samples from one period, so that is not a case of not liking the results of period 2 and then pretending that the subject dropped out from that period and changing the clinical records accordingly.

They may use tools (like DABERS or similar to Anders' SaToWIB) to check that the results of other subjects are not suspiciously similar to those of the dropout subjects.

In any case, if the samples have already been analysed, they have already been analysed and you cannot go backwards in time to de-analyse them. Just keep all records ready, and answer any question in a clear, honest and transparent manner.

Regards
Ohlbe
shreyas goswami
☆    

India,
2024-06-06 22:26
(11 d 18:13 ago)

@ Ohlbe
Posting: # 24023
Views: 472
 

 Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission

Thank you dear all:-),


This will definitely help to build a sound confidence to respond if any.


Regards,
Shreyas Goswami
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