Preclinical development
Pre-clinical development is a stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected.
The main goals of pre-clinical studies are to determine a drug's toxicity and pharmacokinetics through animal testing. This data allows researchers to estimate a safe starting dose of the drug for clinical trials in humans. Pre-clinical studies must adhere to Good Laboratory Practices (GLP) in ICH Guidelines to be acceptable for submission to regulatory agencies such as the Food & Drug Administration in the United States.
Typically, both in vitro and in vivo tests will be performed. Studies of a drug's toxicity include which organs are targeted by that drug, as well as if there are any long-term carcinogenic effects or toxic effects on mammalian reproduction.
Animal testing in the research-based pharmaceutical industry has been reduced in recent years both for ethical and cost reasons. Typically, animal testing involves two species (often rodent and dog). The information collected from these studies is vital so that safe human testing can begin.