TESTING FOR TOXICITY,MUTAGENICITY & GENOTOXICITY

Testing for Toxicity

Both short-term or acute and long-term or chronic toxicity testing are carried out to determine the toxic effects of the drug and mortality in animal models.All these tests are carried out under a standard procedure of "GOOD LABORATORY PRACTICE" to safeguard the quality, integrity, and safety of the preclinical trials. Drug Development: Drugs must be approved by the FDA before they can be marketed in the US. Long, costly, and inherently risky: only 1 of 10-15,000 reach FDA approval. Toxicology testing is required to demonstrate that drugs are safe before they can be given to humans.

Testing of Mutagenicity:-

Mutagenicity:-

Mutagenicity refers to the induction of permanent transmissible changes in the amount or structure of the genetic material of cells or organisms. These changes may involve a single gene or gene segment , a block of genes or chromosomes.

Testings:-

Carcinogenicity:-

Ames test  is used as one of the initial screens for potential drugs to test out possible carcinogens.

one of the the 8th test required under the Pesticide Act(USA) and one of the sixth required under Toxic Substance Control Act(USA).

                  

Genotoxicity Testing:-

Genotoxicity testing includes measurement of DNA primary damage that can be repaired and is therefore reversible, as well as the detection of stable and irreversible damage(i.e. gene mutations and chromosomes abberations) that is transmissible to the next generation when it occurs in germ cells and the pertubation in mechanisms is involved in the preservation of the integrity of the genome.