Yura
★    

Belarus,
2016-02-16 11:13

Posting: # 15994
Views: 5,493
 

 volunteer exclusion [Study Per­for­mance]

Hi

How to calculate the bioequivalence with the departure of the volunteer:
  1. the exclusion of physician-researcher
  2. On disposal without explanation
And what document reference?
Kind regards
Yura


Edit: Category changed. [Helmut]
Dr_Dan
★★  

2016-02-16 14:12

@ Yura
Posting: # 15997
Views: 4,661
 

 volunteer exclusion

Dear Yura
Ideally, all treated subjects should be included in the statistical analysis. However, subjects in a crossover trial who do not provide evaluable data for both of the test and reference products (or who fail to provide evaluable data for the single period in a parallel group trial) should not be included. In principle any reason for exclusion of a subject from statistical evaluation is valid provided it is specified in the protocol and the decision to exclude is made before bioanalysis. Exclusion of data cannot be accepted on the basis of statistical analysis or for pharmacokinetic reasons alone, because it is impossible to distinguish the formulation effects from other effects influencing the pharmacokinetics.
I hope this helps.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2016-02-16 14:19

@ Dr_Dan
Posting: # 15998
Views: 4,720
 

 RRT|RTR|TRR?

Hi Dan,

the forum’s jury is still out and we are awaiting its verdict how to deal with the partial replicate design (RRT | RTR | TRR). If a subject drops out after the second period in the sequence RRT I (!) would still include him / her in the estimation of CVwR. More data = better estimate.

Cheers,
Helmut Schütz
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Dr_Dan
★★  

2016-02-16 15:59

@ Helmut
Posting: # 15999
Views: 4,660
 

 RRT|RTR|TRR?

Hi Helmut
you are nitpicking but absolut right. In my reply I referred to a general two-way crossover design.
LG
Dan

Kind regards and have a nice day
Dr_Dan
d_labes
★★★

Berlin, Germany,
2016-02-23 08:40

@ Helmut
Posting: # 16019
Views: 4,326
 

 RRT|RTR|TRR drop outs

Dear Helmut,

» the forum’s jury is still out and we are awaiting its verdict how to deal with the partial replicate design (RRT | RTR | TRR). If a subject drops out after the second period in the sequence RRT
» I (!) would still include him / her in the estimation of CVwR. More data = better estimate.
emphasis by me

Me too. The SAS code of the FDA progesterone guidance forces this also: no missing in the calculation of the intra-subject contrast R-R.

But this requires that drop-outs are not considered as protocol deviation / violation in the study protocol.

Regards,

Detlew
Yura
★    

Belarus,
2016-03-04 07:47

@ Dr_Dan
Posting: # 16047
Views: 3,934
 

 volunteer exclusion

Thanks for the answer Dr_Dan

Kind regards
Yura
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