Bioequivalence and Bioavailability Forum • intrasubject

intrasubject [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2012-01-16 15:50 (5261 d 09:30 ago) – Posting: # 7950
Views: 6,470

Dear Karthik!

❝ they asked to calculate both intrasubject and intersubject CV.

❝ for intersubject they asked to calculate from art.mean and std dev.

OK, we had that before. That’s not correct, but calculate it according to their form anyhow.

❝ for intrasubject they given the statement like that

❝ according to the query 'the intrasubject variability in the reference literature is not consistent with your value'

I guess your CV_intra is (much?) lower than the one given in literature? If published studies were not using an awful bioanalytical method (high CV) WHO might be suspicious that something went wrong in the study, e.g., conversion of a metabolite to the parent in the ion-source in LC/MS-MS. Since metabolites generally have lower CVs that the parent you will get a lower CV than with a method which separates parent & metabolites. Are your mean concentrations substantially higher than in the literature? If yes, get prepared for an inspection.

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Complete thread:

WHO BTIF K2K 2012-01-12 05:15 [Regulatives / Guidelines]
- WHO BTIF Helmut 2012-01-12 13:55
  - WHO BTIF K2K 2012-01-13 05:51
    - WHO BTIF Helmut 2012-01-13 17:05
      - WHO BTIF Ohlbe 2012-01-13 18:41
        
        WHO BTIF Helmut 2012-01-13 18:54
        
        WHO BTIF K2K 2012-01-16 12:51
        
        Inter- or intra-subject CV? Helmut 2012-01-16 13:26
        
        intrasubject K2K 2012-01-16 13:35
        
        intrasubjectHelmut 2012-01-16 14:50
        
        intrasubject K2K 2012-01-18 09:36