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Registertruncation issues [General Statistics]
Hello Dears,
For certain products, ema product-specific bioequivalence guidance states that the main PK variables: AUC0-72,...etc (also stated in the study protocol), Is that mean any subject who miss 72 h will be excluded from AUC0-72 calculations? if yes, there will be around 25% of subjects missed this interval, is that will be acceptable?
Thanks in advance
For certain products, ema product-specific bioequivalence guidance states that the main PK variables: AUC0-72,...etc (also stated in the study protocol), Is that mean any subject who miss 72 h will be excluded from AUC0-72 calculations? if yes, there will be around 25% of subjects missed this interval, is that will be acceptable?
Thanks in advance
Complete thread:
- truncation issuesLoky do 2020-06-24 03:23
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: AUC72 for all IR products Helmut 2020-06-24 10:47
- EMA: AUC72 for all IR products pmohite 2020-06-24 12:08
- EMA: AUC72 for all IR products Helmut 2020-06-24 10:47
Ing. Helmut Schütz