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AM - Week 5&7
Drug Development
Question | Answer |
---|---|
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monitor for adverse reactions -Warning labels may be added to drug if certain side effects exhibited, drug can even be withdrawn -Drug can be licensed after launched for other things |