2010-03-20 12:09
(5004 d 07:51 ago)

Posting: # 4945
Views: 3,705

 ANVISA guidance [Regulatives / Guidelines]

Dear HS,

For ANVISA submission, If more than 10% of samples (plasma concentrations) are missing in one period then do we need to give the the BE result both including & excluding that subject?

Best Regards

Priyanka S

2010-03-22 11:40
(5002 d 08:20 ago)

@ Priyanka_S
Posting: # 4956
Views: 3,297

 ANVISA guidance

Dear Priyanka
If you have taken that subject for stastical evaluation, then i dont think that there is necessary of given result excluding that subject. U can go with including that subject if i m not wrong. :-)

Bharat N.

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! [Helmut]

2010-04-01 17:34
(4992 d 03:26 ago)

@ Priyanka_S
Posting: # 4996
Views: 3,185

 ANVISA guidance

Dear Priyanka_S
If you realize, that samples are missing you have to decide before you start your bioanalysis if you want to include this subject into statistical analysis or not. If you do not want to include this subject into statistical analysis (because missing samples occurred around tmax) you do not need to measure the samples (then you are on the safe side). If this subject experienced an AE possibly related with the study medication you have to measure the samples for safety reasons. In this case you have to document clearly that this subject will not be included into statistical analysis.
It is always a disadvantage to exclude a subject, unless you have pre-specified procedures in your study protocol, otherwise the regulatory authority could always ask to present the evaluation with and without that subject.
I hope this helps

Kind regards and have a nice day
Vienna, Austria,
2010-04-01 17:56
(4992 d 03:04 ago)

@ Dr_Dan
Posting: # 4997
Views: 3,370

 Bioanalysis of dropouts, etc.

Dear Dan!

I agree essentially with all your points, but I would strongly suggest to analyze all samples of dropouts (and even samples of subjects withdrawing consent) as well. I wouldn’t restrict analysis to subjects experiencing AEs. See this thread (especially the end of Ohlbe’s post). If any regu­la­tory authority asks you for PK data of these samples – and you don’t have them “handy”, you will be in a bad position (long-term stability exhausted or the samples are even already discarded).
Another often forgotten point: If a subject drops out at t > tmax in the last period, this subject may serve well in the comparison of Cmax – only AUC is not evaluable (I’ve seen people excluding all data of such subjects from the evaluation – decreasing the power of the study).

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