Bioequivalence and Bioavailability Forum • Mutivariate test for profile similarity

Mutivariate test for profile similarity [Dissolution / BCS / IVIVC]

posted by d_labes – Berlin, Germany, 2011-02-23 15:47 (5239 d 03:13 ago) – Posting: # 6664
Views: 15,001

Dear all,

in

Saranadasa, Krishnamoorthy
"A multivariate test for similarity of two dissolution profiles"
J. Biopharm. Stat. 15: 265-278, 2005

the authors describe a test for the comparison of drug dissolution profiles which is - in the eyes of the authors - more powerful then others, like similarity factor f2, IUT test ...

This test uses the variance-covariance matrix and therefore needs the individual values of %dissolved. But in the examples given in the paper I found only means and SD for the measurement time points.
Thus I couldn't recalculate the authors values for their new delta statistic if I understand their formulas (many matrices in there :cool:

) some days.

My question: Has anybody examples of the application of this test with all necessary data? Is there any code (SAS, R or whatever) out there?

—
Regards,

Detlew

Complete thread:

Mutivariate test for profile similarityd_labes 2011-02-23 14:47 [Dissolution / BCS / IVIVC]
- Mutivariate test for profile similarity yjlee168 2011-02-24 08:50
  - Mutivariate test for profile similarity d_labes 2011-02-24 15:04
- Mutivariate test for profile similarity Aceto81 2011-02-25 12:33
- Anything (?) else than f2 not acceptable in the EU? Helmut 2011-03-01 13:30
  - Really not? d_labes 2011-03-01 16:07
    - Really not? ElMaestro 2011-03-01 20:02
      - SOPs Helmut 2011-03-02 01:06
      - SOPs d_labes 2011-03-02 08:06
    - Really not? Aceto81 2011-03-02 12:28