Code for Note on DDFM in CMC

SAS code for comparability and stability analysis simulations. The comparability simulation file reports the power and Type I error rates for different variations of the Mixed (and paired) model described by "Planning Split‑Apheresis Designs for Demonstrating Comparability
of Cellular and Gene Therapy Products". The stability simulation generates and fits several stability datasets under different settings for amount of within-lot correlation. The stability single-run file fits a particular (simulated) data set to illustrate differences in lot-specific intervals arising due to choice of DDFM option. This is the same dataset as stability_example_data.csv, which may be imported into JMP or other software.

SAS code was constructed with assistance from GPT 5.2 Pro.