In drug development, preclinical development, also named preclinical studies and nonclinical studies is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing, and drug safety data are collected.
The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product's safety profile. Products may include new medical devices, drugs, gene therapy solutions and diagnostic tools.
Each class of product may undergo different types of preclinical research. For instance, drugs may undergo Pharmacodynamics (what the drug does to the body) (PD), Pharmacokinetics (PK), ADME, and Toxicology testing. This data allows researchers to allometrically estimate a safe starting dose of the drug for clinical trials in humans. Most preclinical studies must adhere to GLPs 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.
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Related Conferences: 3rd World Congress on Environmental Toxicology and Health March 30-31,2020 Osaka, Japan; 22nd World Congress on Toxicology and Pharmacology April 22-23, 2020 Kyoto, Japan; Annual Conference on Inhalation Toxicology October 22-23, 2020 Helsinki, Finland; 19th International Conference on Global Toxicology and Risk Assessment November 05-06, 2020 Madrid, Spain
Related Associations: Spanish Society of Cardiology, European Society of Cardiology, World Heart Federation, Brazilian Society of Toxicology, European Centre for Ecotoxicology and Toxicology of Chemicals(ECETOC), Academy of Toxicological Sciences, American College of Toxicology, Association of Comparative and Environmental Toxicology, Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, Egyptian Society of Toxicology.
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