Island country (time to leave the EU?) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2011-12-16 21:31 (4486 d 19:00 ago) – Posting: # 7786
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Dear all,

just received a deficiency letter from the UK.
  1. Please provide the name and the location of the study site.
  2. Please provide the name and professional address of the principal investigator.
  3. Please provide justification for performing the study in fasted state. The comparator does not provide the recommendation regarding the fasted or fed state for dosing.
  4. Please confirm whether the period or sequence effects were observed in the study. Please provide a comment on their relevance for the study results if they were observed.
Well:
  1. Given on the title page of the report, the synopsis, Section 6, and, …
  2. Given in the synopsis, Sections 5.4 and 16.1.4
  3. In general, a bioequivalence study should be conducted under fasting conditions as this is considered to be the most sensitive condition to detect a potential difference between formulations. For products where the SmPC recommends intake of the reference medicinal product on an empty stomach or irrespective of food intake, the bioequivalence study should hence be conducted under fasting conditions.
    Since nothing was stated in the reference’s SmPC the study was performed in fasted state.
  4. A test for carry-over is not considered relevant and no decisions regarding the analysis (e.g. analysis of the first period only) should be made on the basis of such a test. The potential for carry-over can be directly addressed by examination of the pre-treatment plasma concentrations in period 2 (and beyond if applicable).”
    Not a single pre-dose value >BQL; period and sequence >0.38 for all metrics. Tables were provided in the report.
What the heck? :angry: OK, OK, (3) and (4) are really very, very difficult issues – but (1) and (2)?!

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