The @entity137 profile of the antidepressant drug @entity3756 was determined in a series of preclinical studies in @entity19 , @entity35 , @entity95 and @entity235 . Acute, subchronic, reproductive, chronic and carcinogenicity studies were conducted by the oral route. The highest doses tested in these studies were the maximum tolerated doses based on clinical signs, @entity1907 , body weight effects, organ weight changes or clinical/anatomical pathology findings. @entity74 studies were also performed. The liver was identified as a target organ in the @entity19 , @entity35 and @entity235 . The observed liver findings were consistent with hepatic xenobiotic-metabolizing enzyme induction and included @entity382 , hepatocellular @entity1184 , slightly increased serum transaminase activity and proliferation of smooth endoplasmic reticulum. Hepatocellular fatty change, a minimal toxic effect, was seen in @entity19 and @entity35 . There was no teratogenicity in studies conducted at maternally toxic doses in @entity35 and @entity95 . Decreased neonatal survival and growth observed in these studies have been previously reported in reproduction studies with other @entity750 reuptake inhibitors. @entity3756 was not genotoxic in an extensive battery of tests. Carcinogenicity tests were negative in @entity35 , while benign liver @entity5 were slightly increased in drugtreated male @entity19 . @entity96 were considered secondary to the enzyme inducing potential of @entity3756 and not indicative of @entity1 risk.

Preclinical toxicological evaluation of XXXX .

@entity1 :: ('9606', 'Species') :: ['human'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity96 :: ('MESH:D008113', 'Disease') :: ['Liver tumors'] @entity19 :: ('10090', 'Species') :: ['mice', 'mouse'] @entity235 :: ('9615', 'Species') :: ['dog', 'dogs'] @entity1184 :: ('MESH:D006984', 'Disease') :: ['hypertrophy'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumors'] @entity95 :: ('9986', 'Species') :: ['rabbits'] @entity3756 :: ('MESH:D020280', 'Chemical') :: ['Sertraline', 'sertraline'] @entity74 :: ('MESH:D030342', 'Disease') :: ['Genetic toxicity'] @entity750 :: ('MESH:D012701', 'Chemical') :: ['serotonin'] @entity382 :: ('MESH:D006529', 'Disease') :: ['hepatomegaly'] @entity35 :: ('10116', 'Species') :: ['rat', 'rats'] @entity1907 :: ('MESH:D014397', 'Disease') :: ['decreased food consumption']
@entity3756 :: (MESH:D020280,Chemical) :: ['sertraline hydrochloride']
