Table 2 LMM/OLS tolerance interval width ratios for 6 of the most common CQAs per unit operation. Due to the strong random effect, the LMM interval is generally much wider than the OLS interval
From: Incorporating random effects in biopharmaceutical control strategies
UO 1 | UO 2 | UO 3 | UO 4 | UO 5 | UO 6 | UO 7 | UO 8 | |
|---|---|---|---|---|---|---|---|---|
CQA 1 | 1.85 | 3.80 | 2.67 | 3.18 | 3.01 | 1.57 | 1.17 | 1.08 |
CQA 2 | 1.62 | 1.65 | 6.15 | 3.36 | 4.59 | 3.37 | 2.38 | 5.15 |
CQA 3 | 1.70 | 4.99 | 3.43 | 4.06 | 2.43 | 2.34 | 1.41 | |
CQA 4 | 1.85 | 1.64 | 1.77 | 1.12 | 4.38 | 8.95 | 2.84 | |
CQA 5 | 1.80 | 4.58 | 1.37 | 8.34 | 2.92 | 3.10 | ||
CQA 6 | 1.67 | 1.25 | 9.02 | 3.46 | 2.98 |