Is .sbproject files accepted by US FDA for IND ectd submission?

Hi

As part of the US IND submission, we will have to provide the QSP model files that have been developed by a consultant using simbiology. The model files are of .sbproject format. However, when we looked at FDA acceptable formats (https://www.fda.gov/media/85816/download), they are open to accepting .m or .mat files. They have not specified the .sbproject file format.

My question is have any in the community submitted .sbproject files to US FDA for the IND or NDA submissions and were accepted?

If not, the next question is whether it is easy to change .sbproject files to .m or .mat format ?

TIA

Vinu

Answer 1

[Rick Paxson]

Hello Vinu,

I am aware of submissions to the FDA in sbproj format from SimBiology.

That said, if you are required to submit the model alone, it can be saved in a MAT-file. Simply export the model from SimBiology to the MATLAB workspace

and use the save command in MATLAB:

>> save('qspmodel', 'model')

Assuming 'model' is the name of the variable in MATLAB.

While sending the FDA a MAT-file satisfies their published file format requirements, they will need MATLAB and SimBiology to do anything with that model, therefore it works just as well to send the sbproj file (sbioloadproject loads the model). The benefit of the sbproj file is that in addition to the model other pieces of data will be included, such as:

1. The graphical layout of the model.
2. Any programs (e.g., simulations, parameter fits, etc.) built by the authors/users of the model.
3. Data that might have been used for model calibration.

I hope this helps. Please let me know if you need more information.

[Vinu Menon]

Hi Ricardo

Thanks very much. This is very helpful.