Dissolution similarity [Dissolution / BCS / IVIVC]

posted by Nirali  – India, 2010-11-10 11:13  – Posting: # 6135
Views: 22,521

Dear friends,

I have received a regulatory query to check disso similarity.

Query is:

To do a statistical comparison of the dissolution profiles of the 10mg and 20mg strength at PH 6.8 according to the - "Model Independent Multivariate Confidence Region Procedure”. Calculate confidence interval of Mahalanobis distance (DM) and a respective similarity limit (RD).

(Reference: Dissolution Testing of Immediate Release Solid Oral Dosage Forms, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), August 1997) as described in the revised module 3.2.P.2.2).

My data is:
I have two software: SAS 9.1.3 (but not having SAS/IML) and WinNonlin 5.3.
SAS 9.1.3 also not supporting to Hotelling's T² method.

Is there any other SAS program to calulate above model with SAS/STAT?
Pl. guide me to resolve the query.

Thank You.


Edit: Category changed. [Helmut]

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