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Back to the forum  Query: 2017-04-29 01:48 CEST (UTC+2h)
 
irene
Junior

Greece,
2017-02-13 07:58

Posting: # 17053
Views: 789
 

 Justification for the lack of incurred sample reanalysis [Regulatives / Guidelines]

Hello,

in the EMA's "Questions & Answers: positions on specific questions addressed to the Pharmacokinetics Working Party (PKWP)" it states the lack of incurred sample reanalysis data for a bioequivalence study can be justified. One of the points that should be adreessed is
  • 90% confidence interval:
    As one element of such justification, if applicable, the applicant could also take into consideration the width of the 90% confidence interval and the ratio to possibly justify that a false positive outcome due to ISR problems has a low probability.
I would like to ask if someone has ever provided these data and how the probability of a false positive outcome can be calculated. I was thinking of using simulations but it is not clear which parameters should I vary and which distributions to use (i.e. mean and sd).

Thank you in advance,

Irene
Dr_Dan
Senior

2017-02-14 17:20

@ irene
Posting: # 17058
Views: 555
 

 Justification for the lack of incurred sample reanalysis

Dear Irene
Please search the forum and you will find a lot of discussion on ISR. The guideline put an expiry date on old studies. If you now submit a study without ISR then this study does not reflect current scientific knowledge and will be certainly rejected. IMHO you can not argue the absence of ISR with 90% confidence interval even if the study result is not borderline.

Kind regards and have a nice day
Dr_Dan
irene
Junior

Greece,
2017-02-15 07:56

@ Dr_Dan
Posting: # 17059
Views: 526
 

 Justification for the lack of incurred sample reanalysis

Dear Dr_Dan,

thank you for your answer.

Yes, the study is old, conducted in 2007, but the submission regards a RUP, and I was wondering whether the study can be accepted even though ISR is missing.

Kind regards,
Irene
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