LOCAL TOXICITY STUDIES
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Dermal Upto 2 wk I,II 1sp;4wk
III 2sp;4wk
>2wk I II III 2sp:12wk
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Ocular or Otic Upto 2 wk I II 1sp;4wk
III 2sp;4wk
>2 wk I II III 2sp;12wk
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Vaginal or Rectal Upto 2 wk I II 1 sp;4wk
III 2 sp;4wk
>2wk I II III 2sp;12wk
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NUMBER OF ANIMALS REQUIRED FOR REPEATED - DOSE TOXICITY STUDIES
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DURATION OF 14-28 DAYS STUDY 84-182 DAYS STUDY
TREATMENT
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GROUP Rodent Non-rodent Rodent Non rodent
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Control 6-10 2-3 15-30 4-6
Low dose 6-10 2-3 15-30 4-6
Intermediate dose 6-10 2-3 15-30 4-6
High dose 6-10 2-3 15-30 4-6
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The parameters to be monitored and recorded in long - term toxicity studies include behavioural physiological biochemical and microscopic observations in case of parenteral drug administration the sites of injection are also to be examined grossly as well as microscopically initial and final electrocardiogram and fundus examination may also be carried out in the non -rodent species
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