|
NDA
20-358 |
4 |
3)
Bodyweight
No drug effects
4)
Food
consumption
No drug effects
5)
Ophthalmoscopic
exam
(Done pre-study, at termination, and after recovery)
6)
Hematology
(Done pre-study, wks 7 and 13, and wk 2 of recovery
period)
a)
WBC
were increased in MD F and both HD F groups, not D-R, at 7 wk and 13 weeks
(mean 1.5 x control) but not during recovery period. This was primarily due to increased numbers
of lymphocytes.
b)
RBC,
Hb, and Hct were equivocally very slightly decreased in all F groups, not D-R,
at week 13 and during recovery period.
c)
Other
parameters measured: Rest of WBC differential, platelets, reticulocytes, RDW.
7)
Blood
Chemistry
(Done pre-study, wks 7 and 13, and wk 2 of recovery
period.)
No clear drug effects. Total protein and albumin tended to very slightly increased in all groups but LDF, not D-R.
Other parameters measured: ALT, AST, AP, total
bilirubin, BUN, creatinine, Na, K, glucose, globulin (by subtraction).
8)
Urinalysis
(Done in 4/sex/dose pre-study, wks. 7 and 13, and wk
2 of recovery period.)
The sponsor states no drug effect: however for small N used makes drug effects difficult to detect.
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