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药物 Drug -生物名词

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Any molecule that affects a biological process. More strictly, a molecule whose pharmacological activity can be correlated with its chemical structure. Historically, drugs were identified and extracted from naturally occurring fungi, plants, and other flora and fauna, with little direction given to the targeting of a particular disease. Increasingly, however, modern drugs are being discovered through the precise targeting of a particular disease state dissected at the molecular level, and the drugs may be genes, the protein products of genes (such as recombinant insulin or erythropoetin), or small molecules created by design or diversity to modulate a specific disease process. Irrespective of the process of novel drug discovery, all drugs must undergo a lengthy process of preclinical and clinical review; the first preclinical review tests the viability and usefulness of the drug in model organisms (usually mice, rats or higher primates); and the second review (clinical trials, split into four phases) tests the safety, efficacy and dosage of the drug in humans. The culmination of these reviews (which typically take 3-5 years and can cost from $50-$200 million) is a submission to the issuing authority of the host country’s government (in the U.S, Food and Drug Administration.). Only once this authority has reviewed the data on the drug and agreed that it offers therapeutic benefit without serious side effects is the drug approved for manufacture and sale.

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