Bioequivalence and Bioavailability Forum • Traceability

Traceability [General Statistics]

posted by Helmut – Vienna, Austria, 2023-02-11 14:22 (832 d 09:26 ago) – Posting: # 23455
Views: 3,827

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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Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body. Leslie Z. Benet

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