PHARMACOLOGY

 PRE-CLINICALINON/CLINICAL TOXICITY STUDIES ::

Various the safety tests or toxicity tests carried out in animals before a drug is administered to human beings (clinical trial) can be grouped into two :

1.General Toxicity Study 

2.Specialized Toxicity Study 

In General toxicity study the compound is given to evaluate systemic effects and practically all the organs are examined Specialized toxicity studies are far particular organ or system toxicity 

General Toxicity Studies ::

Acute toxicity ::

In this study a drug is tested to determine LD50 i.e. Lethal dose for 50% of mortality (death) in a group of animals Various doses of the drug estimated to cover the range from 0 to 100% mortality are administered to a group of 10 animals The mortality in each group within a fixed period of time (e.g.one day or two days etc ) is determined The data are plotted as % mortality against the dose of drug and LD50 is determined using standard statistical procedures such as probits Acute toxicity is carried out in two species preferably one rodent and another non -rodent 

Acute toxicity test is a crude and relatively uninformative test for example it does not measure sub-lethal toxicity long term effects or idiosyncratic reactions