NDA 20-358

5

 

 

9)       Organ weights

 

a)       Liver

 

Absolute and relative weights increased  at all doses, D-R.  (Mean rel. wt. in HD groups approx 1.4 x control.  No clear overall difference between HD and HD*).  Increase still seen after recovery period (except at LD); the increase in F after recovery period was slightly smaller than that seen at termination, but N too small to conclude this confidently.

 

b)       Thyroid

 

Slight increase in abs. and rel. wt in both HD M groups.  (The effect at HD* was equivocally greater than that at HD; mean rel. wt. 1.29 and 1.13 x control, resp).  No clear effect after recovery, but note small N.

 

c)       Adrenal

 

Slight increase in abs. and rel. wt in both HD M groups (Mean rel. wt. approx. 1.3 x control; no clear difference between HD and HD*).  No clear effect after recover, but note small N.

 

d)       Kidney

 

Abs. and rel. wt. equivocally and slightly (mean rel. wt. about 1.2 x control) increased in MD M and HD M groups; not D-R; equivocal increases also seen after recovery.

 

10)    Gross pathology

 

No drug effects

 

11)    Microscopic pathology

 

(Routine exam done in controls and both HD groups at termination, and in all animals which died or were prematurely sacrificed.  Among recovery animals, only male kidney, in the control and both HD groups only, was examined.

 

 


Back a Page
Next Page
Back to Wellbutrin SRŪ NDA Index Page
Back to Main Index

Hosted by www.Geocities.ws

1