BIO200H5 Lecture Notes - Lecture 5: Hepatotoxicity, Paracetamol, Furanocoumarin
Document Summary
Drug can be marketed before phases 1 and 2 are done. Some factors can complicate the clinical trials: Variable natural history of the disease accelerate the process for drug to get into the market. Ex. drug-drug interaction; lifestyle; genetic variations = changes to. Ex. nurses administering drug/placebo to women with breast cancer, subconsciously skewed results and gave actual treatment to advanced cancer patients and placebo to patients with less forms of cancer. In order to correct - we apply the double-blind design. Observer bias: corrected by double-blind design (only 3rd party knows order) Nurses and doctors only have barcodes and numbers which reduces from human empathy and allows proper results to be formed - data is collected and printed and sent to third party to then analyze. Acetaminophen: improper use/dosing = leading cause of acute liver failure in canada. Max daily allowance = 4 grams (~8 pills) - average before toxic effects (sometimes less)
