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First point Cmax [Study Assessment]

posted by auditor – India, 2012-02-10 07:50 (5243 d 23:35 ago) – Posting: # 8091
Views: 11,277

Dear All,

In one of the our study we have observed some first point C-max value, 3 out of 54 observation of test product and 13 out of 108 observation of reference formulation.

Kindly give your suggestion about how the agency will take this issue and is it affect the study?

Regards,

Auditor

Edit: Category changed. [Helmut]

Complete thread:

First point Cmaxauditor 2012-02-10 06:50
- First point Cmax drgunasakaran1 2012-02-10 07:00
  - First point Cmax rana 2012-08-18 06:48
    - First point Cmax drgunasakaran1 2012-08-21 07:01
- First point Cmax lukamar 2012-09-10 13:54

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First point Cmax [Study As­sess­ment]

Complete thread:

First point Cmax [Study Assessment]