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RegisterANVISA guidance [Regulatives / Guidelines]
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
Dan
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
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- ANVISA guidance Priyanka_S 2010-03-20 11:09 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ANVISA guidance bharat 2010-03-22 10:40
- ANVISA guidanceDr_Dan 2010-04-01 15:34
- Bioanalysis of dropouts, etc. Helmut 2010-04-01 15:56
Ing. Helmut Schütz