Bioequivalence and Bioavailability Forum • WHO BTIF

WHO BTIF [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2012-01-13 18:05 (5264 d 07:26 ago) – Posting: # 7932
Views: 6,496

Dear Karthik!

❝ study was two way crossover.

OK, so definitely no way the calculate (any!) CV from ANOVA separately for the two treatments.

❝ In reference literature they given geo.mean means its possible to calculate.

What do you mean by that?

❝ In query they specifically asked intersubject CV for reference literature.

Well, even in the few replicate designs published only the intra-subject CV of the reference is given. CV_inter is completely irrelevant in BE (unless it’s a parallel design, of course).

❝ but we calculated inter and intra subject CV for our study report for last time query and we mention intersubject CV is not available for reference literature.

Correct.

❝ Again they send same query and asked to calculate intersubject CV from arth.mean and standard deviation.

If they refer to this strange form, simply give them what they want. You and I know that 100·SD/x_R ≠ CV_inter.

❝ its possible to compare our study report with reference literature?

Sure, but of limited value.

❝ we try to compare but some times the values are not match means what we want to do?

Nothing. Especially if CV_inter is high (especially for drugs subjected to polymorphic metabolism) differences between studies of up to 50% don’t really surprise me.

❝ sometimes values may change according to condition of subjects, formulation and any other reason.

Exactly. I would add: posture, bionanalytics.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

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 BTIFHelmut 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
        
        intrasubject Helmut 2012-01-16 14:50
        
        intrasubject K2K 2012-01-18 09:36