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What is involved in preclinical testing of drugs?

Once a drug candidate has been identified in the laboratory, it begins years of testing. It starts with lab and animal studies to evaluate its safety and demonstrate that it has biological activity against the disease target. 
Key preclinical tests include pharmacokinetics, the study of how drugs move through living organisms. Scientists examine four key processes - absorption, distribution, metabolism, and excretion - to ensure that the medicine reaches its intended target and passes through the body properly.
In addition to biological tests, researchers conduct a number of other preclinical studies. Chemistry tests establish the compound's purity, stability, and shelf life. Manufacturing tests determine what will be involved in producing the medicine on a large scale. And pharmaceutical development studies explore dosing, packaging, and formulation (for example, pill, inhaler, injection).
The main goal of preclinical studies is to rigorously assess safety before human tests begin and this can take anywhere from 3-6 years. Some preclinical safety tests continue even after the start of clinical trials in people to determine if there are any long-term adverse effects researchers should look for.

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