DISSOLUTION SIMILARITY

[jn_som]

What inspired this wish list request? 

To respond the query for Pharmaceutical Regulatory body.

What is the improvement you would like to see? 

In recent version of JMP 17, dissolution similarity features included that is really appreciating from the users from Pharmaceutical industry background. However, this new features have few limitation like, we are able to calculate the Dissolution similarity of n=12 units. If we want to establish similarity between Reference (R) and Test product (T) more than 12 units (either 24 or 36 units, if same lot the f2 calculation and if from different lots of R & T>> then f2 matrix) we need to take help of SAS coding experts.

Why is this idea important? 

DDSolver plugin for EXCEL is freely available (which worked for 12 no. of units). If JMP will include this feature for more than 12 units, it would be a special proposition, not only for Pharma Industreis community, also for Pharmaceutical Regulatory bodies like FDA, EMA etc.

[SamGardner]

@jn_som thank you for the the feedback on the new dissolution similarity calculation feature.  We will take this under consideration.  

[jn_som]

@ParsaKarthik and @Varun_Bhatt , please share your thought on this

[MRB3855]

Dissolution similarity is something I have a lot of interest in; I must apologize @jn_som and @SamGardner , however, as I don't understand what the request is asking that the current platform does not offer. Can someone elaborate please?

[MRB3855]

Hi @SamGardner: This comment is really for my own (and perhaps others) clarity. As I understand it from @jn_som , the wish is the be able to compare (via f2 and bootstrapped f2) multiple batches of Test vs multiple batches of Reference; i.e., n>=1 batches of Test vs m>=1 batches of Reference. Usually n=m, but I suppose there could be cases where this is not true.

[SamGardner]

@MRB3855 my understanding of the request is to allow for calculated similarity regardless of the number of units tested in each group.  So, for example, if in formulation development you are evaluating different formulations, you may want to save time and material by only testing 6 units for each formulation instead of 12.  Also, alternatively, you may want to test more units for a formulation or process change, because of the sampling across the batch or due to the dissolution method having high variability. 

Right now, in version 17, for the dissolution similarity calculations, you can choose only one reference batch or material, and all the other profiles are compared to that reference.  

[SamGardner]

We are planning on allowing for as few as 4 unit profiles per batch in the upcoming version of JMP.   

[jn_som]

@MRB3855 & SamGardner, Yes both are absolutely correct about the Wish, which is required to compare the dissolution similarity,

 When we have less number (<12) of Units in Test & Reference and also number of batches of T & R.

@SamGardner , thanks for the update.