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9 Cards in this Set
- Front
- Back
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Stringent criteria for a new medicine |
Safety, efficiency, quality, economic |
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Stages of drug development |
Discovery Preclinical Phase | Phase || Phase ||| Approval Post launch |
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Discovery |
Research into disease mechanisms - key molecules and processes in a disease - reveals potential targets Find agent that acts specifically to target Combinatorial chemistry to make millions of different compounds before screening to see which binds to target Drug companies have no financial interest at this stage |
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Pre clinical |
Involves lab animals Have now identified good target (drug lead) but now need to find out how they’re metabolised - where they go, how body breaks it down, how long they stay there, toxic?, absorbed and secreted, potential side effects. Does the drug inhibit target partially or totally? Enhance good points and minimise bad points |
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Phase | |
Drug development is now narrowed down to one compound. Apply for approval from medicines and healthcare products regulatory authority (MHRA) to run a phase | clinical trial. Clinical trials now involve target species (humans if human drug). - healthy volunteers Starts off with small doses then build up monitoring for any toxicity. Now can see how drug is metabolised in specific species. |
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Phase || |
First time patients are involved. Small number involved and carefully monitored New drug is safe to use and if it has positive effects. Lab animals of target species will still be used so phase | and || overlap |
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Phase ||| |
Data collected so far submitted to VMD or EU to get ‘animal test certificate’ to allow clinical trial Involves many patients hundreds - thousands. Randomised controlled trails - placebo Ideally neither patient or researcher should know who took what - double blind trail Persuade vets and clients to try out medicine - mainly through uni Aim to get huge amounts of data to support safety efficiency and withdrawal periods (farm animals in study cannot be in food chain) Practice quality of product - can it be mass produced Process is expensive |
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Approval |
VMD can issue market authorisation for drug to be sold MHRA for human regulatory approval as well as data sent to national institute of health and clinical excellence NICE - accesses if its good value for money May be to and fro between VMD and drug company to achieve licence Approval process if goes smoothly takes a full year from submission till product in market |
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Post launch |
Reaches market. Still possible for side effects New drugs are monitored after launch by pharmaceutical company and vets use same yellow card ‘suspected adverse reaction surveillance scheme’ monitored by VMD. |
