Bioequivalence and Bioavailability Forum • Justification for the lack of incurred sample reanalysis

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

posted by irene – Greece, 2017-02-15 08:56 (3061 d 21:09 ago) – Posting: # 17059
Views: 3,558

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

Complete thread:

Justification for the lack of incurred sample reanalysis irene 2017-02-13 07:58 [Regulatives / Guidelines]
- Justification for the lack of incurred sample reanalysis Dr_Dan 2017-02-14 17:20
  - Justification for the lack of incurred sample reanalysisirene 2017-02-15 07:56