Bioequivalence and Bioavailability Forum • Traceability

Traceability [General Statistics]

posted by Helmut – Vienna, Austria, 2023-02-11 14:22 (1221 d 23:56 ago) – Posting: # 23455
Views: 6,816

Hi Sereng,

❝ Hi Helmut, I am not sure whether my reply should be at the top or bottom in this forum.

See here and there.

❝ Do you include your BA/BE study SAP with you NDA?

Whatever you planned must be included as appendices to the report. Only then your results are traceable from the raw data.

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Complete thread:

Are Statistical Analysis Plans “required” for Pivotal Studies? Sereng 2023-02-08 18:23
- SAP vs. part of the clinical protocol Helmut 2023-02-09 09:49
  - SAP vs. part of the clinical protocol Sereng 2023-02-10 23:34
    - TraceabilityHelmut 2023-02-11 13:22
- Are Statistical Analysis Plans “required” for Pivotal Studies? Achievwin 2023-02-15 12:07
- Are Statistical Analysis Plans “required” for Pivotal Studies? ElMaestro 2023-02-16 06:55

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