DDSolver, Mahalanobis distance and its 90% CI [Dissolution / BCS / IVIVC]

posted by yicaoting  – NanKing, China, 2011-10-06 16:03 (3339 d 09:58 ago) – Posting: # 7434
Views: 18,600

(edited by yicaoting on 2011-10-06 16:18)

Dear Nirali,

I am the developer of DDSolver, an Excel add-in for analysis of drug dissolution data.

Have you tried DDSolver? It can be accessed here.

This program was developed during my Ph.D study years. It is able to calculate Ms's distance and it's 90% confidence interval. Hope it can help you.

Although users are forbidden to see the code inside the program, it is not important for pharma scientists.

If you want to use DDSolver to calculate Ma's distance, I can promise that I have compared the results of DDSolver with that of the famous paper which might be practically recommended by FDA. Moreover, I have compared DDSolver's Ma's distance with that of Mathematica. Mathematica is a famous numerical analysis software.
Both comparisons are high satisfactor.

Finally, let me use your data to calc Ma's distance and it's 90%CI. The results are as follows:

Some explanations: the conclusion of Reject is obtained based on Max Difference of 10% in between mean dissolution profiles through all the sampling time points as a similarity limit. I used 10mg-formuation as a Reference formulation.

Alternatively, you can specify a certain Ma's distance value as similarity limit which can be obtained from two bathes of your stardard formulations. To do this, you can use DDSolver's MSD Determination for Fration-Time Data module.

I am very glad if someone can compare DDSolver's results with that of other programs.

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