Joint analysis of PK and immunogenicity outcomes using factorization model − a powerful approach for PK similarity study

Table 1 Type I error rate of factorization model by ADA response rate and correlation matrix

Scenario #	ADA response rate (%) ^a	Correlation coefficient of PK and ADA	Type I error rate (%)
1	20%	−0.5	4.86%
2	40%	−0.5	4.85%
3	60%	−0.5	4.92%
4	20%	−0.3	4.98%
5	40%	−0.3	4.92%
6	60%	−0.3	4.86%

For PK parameter data generation, assumed GMR = 0.80 (at the boundary of the standard equivalence margin), assumed geometric CV = 0.4, correlation coefficient of ADA and covariate = 0.1
^a ADA response rates are equal for Test and Reference groups

ISSN: 1471-2288