Drug development

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  • Created by: z
  • Created on: 22-02-16 22:10

Sources of new drugs

  • botanical/zoological
    • investigation of herbal remedies
    • plants, moulds and derived animal products
  • serendipity
    • random discovery (e.g. penicillin)
    • unexpected properties of cuurent drugs (e.g. sulphonamide abs> sulphonylureas for DM)
  • analogues of existing compounds
    • e.g. L-DOPA or insulin
    • beware of differences in pharmacokinetics and phatrmodynamics
  • screening
    • "***** and hope"
    • lengthy, high risk, fewer than 1 in 100 compounds make it to market
  • targeted drug design
    • new approach
  • Also:
    • Gene therapy, stem cell, immunopharmacology etc
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Clinical trials

  • phase I - human pharmacology (~50 ppl)
    • check toxicity and find effective dose
    • pharmacokinetic, pharmacodynamic and early metabolic studies
    • receive clinical trials exemption certificate
  • phase II - therapeutic exploration (~250 ppl)
    • assess efficacy and safey on carefully monitored pt with limited numbers and scope
  • phase II - therapeutic confirmation (~2000 ppl)
    • expand controlled trials
    • receive marketing authorisation ("the licence) 
  • phase IV - therapeutic use
    • post-marketing trials

In total cost ~1billion Euro, takes 15 years+

  • toxic ADRs (i.e. due to dose) seen Pase I-III
  • idiosyncratic (non-dose related) ADRs seen as phase IV progresses
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Licensing

  • pharmaceutical company synthesises, evaluates and trials teh drug
  • licensing authority is advised based on:
    • quality
    • efficacy
    • safety
  • licence granted to market the drug:
    • for specific condition
    • in a sprecific preparation
    • over a specified dose range
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Regulation

  • commission on human medicines (CHM)
    • advises on applications for marketing authorisation
    • promotes "yellow card scheme"
    • provides advice about new safety issues
    • expert advisory groups (e.g. for paediaric drugs)
  • Yellow car scheme
    • record ADRs
  • black triangle
    • inverted black triangle placed on new drugs/vaccines under specific monitoring for safety, record all suspected ADRs for these drugs
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