PCL102H1 Lecture Notes - Lecture 4: Investigational New Drug, Lead Compound, Drug Discovery
27 Apr 2016
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Overall, only 1 in 10 drugs offer significant therapeutic advantage. In vitro and in vivo: investigational new drug (ind) application is filed with the fda contains. Clinical protocols purpose is to obtain permission to test drugs in humans: clinical trials. Design: healthy volunteers, initially small doses, dose escalated until toxicity or pharmacological effect observed, toxicity screened with routine tests. Objective: obtains prelim info on efficacy of drug, determines. > metabolism, main pathways of elimination of drug. Design: patients with disease, large subjective element in human illness (placebo effect) > may use blinding to reduce bias: may also include tests for. > determining optimal dosage for use in phase iii clinical trials. Objective: aims to determine dose-response relationship, evidence of beneficial effect may appear at this stage, most drugs fail at phase ii don"t cure, treat or have measurable benefits. Design & objectives: aims to compare efficacy of drug with current regimen, measure adverse effects and possible benefits at regular intervals.
