Long-term Toxicity Study Objective Procedures Problems >Mechanic? Innovative
Long-term Toxicity Study ▪ Objective ▪ Procedures ▪ Problems ➢Mechanic? Innovative ?
Obiective Toxic dosage a Safety margin Toxic reaction Target organ Reversibility
Objective ▪ Toxic dosage ▪ Safety margin ▪ Toxic reaction ▪ Target organ ▪ Reversibility
Procedures Animals Housing Test article Route Dosage and group Administration duration observation
Procedures Animals Housing Test article Route Dosage and group Administration duration Observation
Procedures 1- animals rodent non-rodent rat beagle dog mouse mongrel dog monkey
Procedures 1--- animals rodent non-rodent rat beagle dog mouse mongrel dog monkey
Procedures 2- housing Diet, T, humidity, light, ventilation a Rat: <5/cage, separated acclimation >lw Dog: TB test, anthelmintic acclimation: 1-w/lm
Procedures 2---- housing ▪ Diet, T, humidity, light, ventilation ▪ Rat: ≤5 /cage , separated， acclimation ≥1w ▪ Dog: TB test, anthelmintic acclimation: 1-2w / 1m