irene ☆ Greece, 2017-02-13 08:58 (2627 d 22:38 ago) Posting: # 17053 Views: 3,645 |
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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
Thank you in advance, Irene |
Dr_Dan ★★ Germany, 2017-02-14 18:20 (2626 d 13:17 ago) @ irene Posting: # 17058 Views: 2,974 |
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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 ☆ Greece, 2017-02-15 08:56 (2625 d 22:41 ago) @ Dr_Dan Posting: # 17059 Views: 2,900 |
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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 |