Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-10-17 05:57 CEST (UTC+2h)
 
irene
Junior

Greece,
2017-02-13 07:58

Posting: # 17053
Views: 1,146
 

 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: 859
 

 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: 829
 

 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
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,394 Posts in 3,725 Threads, 1,071 registered users;
28 users online (0 registered, 28 guests).

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed