Drug Development: Preclinical Development and Testing

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When a drug is developed its safety and efficacy has to be established to qualify for a licence to market it in Ireland – Irish Medicines Board or in the USA from the Food & Drug Administration. The drug undergoes a series of tests to prove its medicinal ability is sufficient for the medicines market. Preclinical Development Preclinical testing performed by graduate researchers (Ph.D level), evaluate the medicines safety and efficacy before the medicine can be tested on humans. The medicine is rigorously tested for a 3-6 year period to assess its safety, biological activity, therapeutic ratio, and side effects in laboratory (in vitro) and on animals (in vivo). In vitro testing the drug is tested on cell cultures and isolated tissues. The concentration effect as are established. Pharmacological and toxicological effects are monitored. In vivo testing on two species of animal one rodent and non-rodent. Toxicological effects; mutagenicity, genotoxicity, teratogenic and carcinogenic are investigated. The lethal dose LD50 toxicity is defined. The dose-response relationship of the adverse effect is observed. Pharmacokinetics how the drug moves through living organisms, adsorption, distribution, metabolism and excretion are examined. The rate and amount of drug delivered to the blood and the dosage regimen to maintain therapeutically effective blood concentrations with little toxicity. What the body does to the drug when administered. Pharmacodynamics is the study of
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