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RegisterDissolution similarity [Dissolution / BCS / IVIVC]
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:
![[image]](img/uploaded/image14.jpg)
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.
Regards,
Nirali
Edit: Category changed. [Helmut]
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.
Regards,
Nirali
Edit: Category changed. [Helmut]
Complete thread:
- Dissolution similarityNirali 2010-11-10 11:13 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Dissolution similarity Nirali 2011-04-21 12:27
- Dissolution similarity Aceto81 2011-04-28 15:14
- Mahalanobis distance - R code d_labes 2011-04-29 15:14
- Dissolution similarity Aceto81 2011-04-28 15:14
- DDSolver, Mahalanobis distance and its 90% CI yicaoting 2011-10-06 16:03
- DDSolver, Mahalanobis distance and its 90% CI Nirali 2012-07-03 07:40
- DDSolver, Mahalanobis distance and its 90% CI d_labes 2012-07-06 10:54
- DDSolver, Mahalanobis distance and its 90% CI Sid 2019-03-07 19:23
- Dissolution similarity Nirali 2011-04-21 12:27
Ing. Helmut Schütz