Bioequivalence and Bioavailability Forum • Significance level in Stability Analysis

Significance level in Stability Analysis [Regulatives / Guidelines]

posted by Ravi – India, 2008-11-20 13:50 (6430 d 07:49 ago) – Posting: # 2748
Views: 4,089

Dear All,

I read in ICH guidlines for stability that a level of significace of 0.25 is to used. But as far as my knowedge is concern significance level is usually taken as 0.05. So Please can any one explane me the statistical rational of choosing signifinace level of 0.25 in testing equality of slope and intercepts in stability analysis.

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Thanks & Regards
Ravi Pandey

Complete thread:

Significance level in Stability AnalysisRavi 2008-11-20 12:50
- Significance level in Stability Analysis d_labes 2008-11-20 15:11
  - Significance level in Stability Analysis Helmut 2008-11-20 15:37
    - Significance level in Stability Analysis Ravi 2008-11-21 05:16
  - Significance level in Stability Analysis Ravi 2008-11-21 06:01
    - Significance, power, hypotheses - what does it all mean d_labes 2008-11-21 09:34
- Significance level in Stability Analysis martin 2008-11-21 10:33