What inspired this Wish List Request?
In bioequivalence (BE) studies within the CMC domain, crossover designs are widely used to reduce sample size while maintaining statistical power.
For example, instead of recruiting two independent groups of 12 subjects each (total n=24), a 2×2 crossover design allows the same 12 subjects to receive both treatments across two periods. This results in 12 paired observations (within-subject comparison), which significantly improves statistical efficiency.
However, the current limitation is that JMP does not provide a dedicated sample size and power analysis platform tailored for crossover equivalence designs.
Users are often forced to:
- Approximate using parallel group assumptions (which is statistically inappropriate), or
- Rely on external tools such as PASS or Phoenix WinNonlin
This creates inefficiencies and breaks the workflow within JMP.
Please describe the new or improved feature or solution you would like to see.
- sample size explorer for 2×2 crossover design (standard BE design)
- If possible,Higher-order crossover designs (e.g., replicate designs) also would be good
What would the value be to you and/or other users if this new feature is provided?
Is this an external customer request?
Yes.
This request originated from Boryung Pharmaceutical.
Is there a competitive software package that has this feature or solution that we should be aware of?
Yes.
The following tools currently support crossover BE sample size and power analysis:
- SAS (PROC POWER, custom programming)
- PASS
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, By expanding the range of capabilities within JMP, we can keep users within the platform and reduce churn.
