Guest guest Posted December 6, 2010 Report Share Posted December 6, 2010 Respected members, Now coming to the actual discussion of the toxicity tests, first we have single dose studies or acute toxicity tests. Done on 2 rodent species Route should be as intended for usage in humans In addition one extra route should be used in animals to ensure proper absorption of the drug. Ideally animals should be grouped into 3 groups and a control 3 graded doses should be used which must be in multiples of doses intended for human use 5 animals/sex/ group used Limit of 2gm/kg or 10 times the normal dose in humans to be used Animals observed for 14 days for MLD and MTD LD50 if possible to be determined Mortality observed for 14 days for oral dosage and 7 days for parenteral drug administration Behavioral and any physical changes in animals if any to be noted All laboratory parameters to be monitored Symptoms, signs and mode of death to be reported Desirable to include histopathology of the affected organ Dr Somesh RayasamJR,Pharmacology dept,GMCH, Nagpur. Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.