Long-Term Safety of PEGylated Coagulation Factor VIII in the Immune-Deficient Rowett Nude Rat

Table 2

Sampling/examination schedule.

	Before dose	Day 1	Week 13	Week 26	Week 30	Week 48	Week 52	Recovery week 2	Recovery week 12	Recovery week 26
Toxicokinetic profile		X + O		X + O			O
Antibody analysis				X + O			O	X + O
Biochemistry, hematology, and coagulation			X + O		O	O			O	X
Urinalysis				X			O		O	X
Ophthalmoscopy	X + O			X			O

Note. X, only in 26-week study; O, only in 52-week study.
all week 26 female main study animals, blood samples for biochemistry, hematology, and coagulation were taken two to four days after last dose and not 12 hours after dose as originally planned.
Toxicokinetic profile: samples taken before dose and at 0.25, 1, 4, 8, 12, 24, 48, and 96 hours after dose administration.