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.Thepregnancy losses of five of the 300 mg/kg/day females were preceded by bodyweight loss, reduced food intake and reduced fecal output; the sixth femalehad no significant history.It is known that adverse treatment, including dietarydeprivation (Matsuzawa et al., 1983), can lead to abortion in rabbits.Thus,all of the abortions observed in this study can be considered to be related tochanges in maternal status, with PP 27567-related maternal toxicity contributingto the increased incidence of abortion when the drug was administered at300 mg/kg/day.Example 6.7 Abortions not related to the test compoundOne control female, two females in the 30 mg/kg/day group and one female inthe 300 mg/kg/day group aborted during the study.In view of the groupdistribution and the absence of a treatment-relationship, involvement of PP 27567was considered unlikely.6.5 Body Weight DataDescribe body weight changes relative to dose and sex.As a rule, descriptionsof body weight changes refer to group mean changes for rodents and rabbits,and individual animal change for large animals, i.e.dogs and monkeys.Withtwo different control groups, e.g.in intravenous studies which include a vehiclecontrol and a saline control group, group mean body weight changes in treatedgroups should always be related to vehicle control group means.Body weightchanges in large animals may be related to the control group or to individualbody weights at study initiation.Be clear of your meaning when expressingchanges in body weight versus changes in body weight gain.Generally, it issimpler not to attempt to describe a lower mean body weight gain, but insteadto refer to lower group mean body weights in treated groups at study terminationor at interim weighing points.Whenever there are multiple changes in bodyweight across treated groups, they may be described using a table (see Example6.9).Please note that the term  body weight is generally used in the singular unlessone refers to several groups or specifically to several animals, e.g. Body weightin the group receiving 74 mg/kg/day was unaffected.There was no compound-related change in body weight in the groups receiving 75 or 150 mg/kg PP 46567.But:  5/10 animals receiving 55 mg/kg/day had lower body weights.55Presenting toxicology resultsExample 6.8 Body weight dataPP 27567 produced dose- and compound-related effects on body weight: onday 29, males treated with 100 and 300 mg/kg/day had a lower mean bodyweight ( 8% and  12%, when compared with control values); in females, therespective mean body weight differences on day 29 at 100 and 300 mg/kg/daywere  11% and  16%, respectively.The difference in body weight was statisticallysignificant at 300 mg/kg/day for both male and female groups.No effect onbody weight was observed in the groups receiving 30 mg/kg/day.Example 6.9 Body weight tableTable 6.5 PP 27567:6-Month repeated dose toxicity in rats mean bodyweight on days 62, 127 and 182 of the study (percentage change comparedwith control mean values).*p [ Pobierz całość w formacie PDF ]