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Table 1 Experimental dosage regimens for toxicity study of AFM tartrate in male and female rats

From: Toxicity and radiation dosimetry studies of the serotonin transporter radioligand [18 F]AFM in rats and monkeys

 

Male

Female

Vehicle

1,000× human dosage a

100× human dosage a

Vehicle

1,000× human dosage a

100× human dosage a

No. of animals

 

10

10

10

10

10

10

Dose per day

By surface area (μg/m2)

0

5,920

592

0

5,920

592

By body weight (μg/kg)

0

987

98.7

0

987

98.7

No. dosages

 

1

1

1/5

1

1

1/5

Total dosage (μg/kg)

 

0

987

98.7/493.5

0

987

98.7/493.5

Dosage volume (mL/kg)

 

7.58

7.58

7.58/7.58

7.58

7.58

7.58/7.58

Rats killedb

       

Interim

Day

3

3

3/7

3

3

3/7

 

No. of killed

5

5

5/5

5

5

5/5

Terminal

Day

15

15

15/19

15

15

15/19

 

No. of killed

5

5

5/5

5

5

5/5

  1. aMaximum human dose is 8 μg per 50-kg person, i.e., 0.16 μg/kg; 0.16 × 37 = 5.92 μg/m2. Scaling for the rat gives 5.92 μg/m2/6 = 0.987 μg/kg as an equivalent human dosage. 1,000 × 0.987 = 987 μg/kg as the high dosage; bFive rats in each group and of each sex were killed on day 3 (2 days following single dosing) and five on day 15 (14 days following single dosing). Five rats in each group and of each sex were killed on day 7 (2 days following 5-day dosing) and five on day 19 (14 days following 5-day dosing). Dosing of the 5-day dosing animals was initiated 4 days prior to dosing of the single-dose animals so that necropsies occurred on the same calendar day for all groups, thus allowing sharing of control clinical pathology and necropsy data between the two dosage regimens.