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AM - Week 5&7

Drug Development

QuestionAnswer
What Is The First Step In Drug Development? Drug Discovery -Research into a specific disease and key molecules -Finding of a specific agent that will target those molecules -Involves searching for natural compounds, or using combinatorial chemistry to make millions of compounds to screen
What Is The Second Step In Drug Development? Preclinical Trials -Study of compounds in more detail, how they are metabolised -Computerised trials to test for toxicity -Trials on lab animals (3 Rs of scientific procedures act)
What Is The Third Step In Drug Development? Phase I Trials -Narrowed down to one compound -Takes place in the lab -Tests for safety in target species (healthy animals)
What Is The Fourth Step In Drug Development? Phase II Trials -Tests for drug efficacy -Trials for unwell patients (with target disease) - small population
What Is The Fifth Step In Drug Development? Phase III Trials -Randomised controlled trials -Large group of patients tested – in practice -Use of a placebo (double blind trial) -Need animal test certificate from VMD + get practice on board for trials
What Is The Sixth Step In Drug Development? Approval and Launch, Or Phase IV Trials -Additional commercial trial by company to compare drug to competitors -Also research to answer questions from veterinary professionals
What License Is Required For A Drug To Be Sold Commercially On The Market? VMD marketing authorisation
What Happens During The Post Launch Stage Of Drug Development? -Company continues to monitor drug on market -SARSS scheme to monitor for adverse reactions -Warning labels may be added to drug if certain side effects exhibited, drug can even be withdrawn -Drug can be licensed after launched for other things
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