PCL102H1 Lecture 7: Drug Safety for Drug Development

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Document Summary

Drug safety for drug development: fits in the discovery/preclinical testing section of the drug discovery pipeline. First do no harm: guiding principle for physicians, concept from the hippocratic oath. Why are we concerned about drug safety of new drugs in the pipeline: historical concern, safety problems with marketed drugs. When in the drug discovery pipeline do preclinical toxicity tests occur: these tests are happening in parallel times because we want to save time. I(cid:374) (cid:448)it(cid:396)o = (cid:862)i(cid:374) glass(cid:863) -> can mean biochemistry experiment or cell culture experiment: safety concern does the drug cause cancer in people? (in vivo question) Indirect safety test does the drug damage dna of bacteria? (in vitro question) Toxicology: detective work: toxicity may be caused by the drug or by one of its metabolites, major mechanisms, reversible binding of drug to receptor, activation of drug to metabolite that binds/damages protein, dna.

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