Study Time Period Desoription

Single doses are given and

Acute Toxicity animals are observed for
1-3 days
overt effects and mortality.
LD50 value is determined.
Repeated doses selected on
the basis of ED50 and LD50
Sub acute Toxlcity 3 days-1 monthare gven and animals
examined for overt effects,
are

food intake, body weight and

other hematological factors.
Small doses are given for
Chronic Toxlcity 6-12 months long time period and then
their effects are determined.
 OB.JECTIVES OF THE TOXICITY STUDY
T o identify any toxie substance prior to clinical use.

Qualitative and Quantitative assessment of drug use.

Mostly used to examine specific adverse events or specific end points such as cancer
cardiotoxicity, skin/eye irritation.

Different typesof dose identification be done. (MLD, LD0. MTD. ED. NOAEL)
can

Prediction oftherapeutic index (LD0/ED)

Benefit-risk ratio can be calculated.

T o relate the toxicological findings toclinical safety.

6
To support in selecting
clinical toxicity studies
species, treatmet regimen and designing subsequent non