Toxicology testing

Toxicology testing, also known as safety assessment, or toxicity testing, is conducted to determine the degree to which a substance can damage a living or non-living organisms. It is often conducted by researchers using standard test procedures to comply with governing regulations, for example for medicines and pesticides. Much toxicology is considered to be part of the field of preclinical development. Stages of in vitro and in vivo research are conducted to determine safe doses of exposure in humans before a first-in-man study. Toxicology testing may be conducted by the pharmaceutical industry, biotechnology companies or contract research organizations.

History

Europe

Around one million animals, primate and non–primate, are used every year in Europe in toxicology tests.[1] In the UK, one-fifth of animal experiments are toxicology tests.[2]

Methodology

Toxicity tests examine finished products such as pesticides, medications, food additives such as artificial sweeteners, packing materials, and air freshener, or their chemical ingredients. The substances are applied to the skin or eyes; injected intravenously, intramuscularly, or subcutaneously; inhaled either by placing a mask over the animals and restraining them, or by placing them in an inhalation chamber; or administered orally, through a tube into the stomach, or placing them in the animals' food. Doses may be given once, repeated regularly for many months, or for the lifespan of the animal. Toxicity tests can also be conducted on materials need to be disposed such as sediment to be disposed in marine environment.

Contract research organizations

A contract research organization (CRO) is an organization that provides support to the pharmaceutical, biotechnology, chemical, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide toxicity testing services, along with others such as assay development, preclinical research, clinical research, clinical trials management, and pharmacovigilance. CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMEA, etc.).[3]

Regulation

United States

In the United States, toxicology tests are subject to Good Laboratory Practice guidelines and other Food and Drug Administration laws.

See also

References

  1. ↑ Abbott, A (November 10, 2005). "Animal testing: More than a cosmetic change" (PDF). Nature. 438 (7065): 144–146. doi:10.1038/438144a. PMID 16281001.
  2. ↑ Select Committee on Animals in Scientific Procedures Report, House of Lords, Chapter 3: The purpose and nature of animal experiments.
  3. ↑ "The CRO Market", Association of Clinical Research Organizations.

External links

This article is issued from Wikipedia - version of the 6/30/2016. The text is available under the Creative Commons Attribution/Share Alike but additional terms may apply for the media files.