What inspired this Wish List Request?
When performing dissolution F2 comparative analysis, Korea FDA requires "Expected F2 + Percentile CI," identical to the EMEA guideline. Many pharmaceutical customers require this functionality. However, JMP currently only provides Estimated F2 + BCa CI.
Please describe the new or improved feature or solution you would like to see.
No additional materials to attach at this time.
What would the value be to you and/or other users if this new feature is provided?
If Expected F2 + Percentile CI were supported in JMP, pharmaceutical customers in Korea would be able to perform regulatory-compliant dissolution similarity analysis entirely within JMP, eliminating the need for alternative software and significantly improving workflow efficiency.
Is this an external customer request?
Yes. This request has been raised by numerous customers including Ahn-Gook Pharmaceutical, Boryung Pharmaceutical, Panmix, and Daewoong Pharmaceutical, among many others. In fact, this is the single most frequently requested development item from the Korean market.
Is there a competitive software package that has this feature or solution that we should be aware of?
Will this impact a renewal, expansion, or adoption at a customer, and does this put an account at risk if we do not address this?
Yes, this directly impacts adoption. Without this feature, customers who are required to follow Korea FDA and EMEA dissolution guidelines cannot fully rely on JMP for their regulatory submissions, which puts both new adoptions and existing account renewals at risk.
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