Drug discovery and development

?
  • Created by: MazzaW
  • Created on: 07-12-19 11:08
View mindmap
  • Drug discovery and development
    • Process
      • Research
        • Discovery
          • Preclinical development
            • Phase 1
              • Phase 2
                • Phase 3
                  • Approval and launch
                    • Ensure safety and efficacy
                      • Therapeutic trials
                    • Ensure quality
                      • Medicine contains active ingredients in stated dose + stated excipients and nothing else
                    • Can prescribe unlicensed drugs but with greater legal liability
                  • Patient groups
                    • 500-2000 over 2-4yrs
                    • Compare with placebo
                    • Establish clinical benefit
                • Use in patient groups
                  • 50-300 over 2-5 yrs
                  • Effective dose range
                  • Common adverse effects
              • Healthy volunteers
                • Dosing- single and multiple dosing
                • 20-50 people over 1yr
                • Interactions
            • Establish pharmaco-logical action
            • Animal testing
              • Safety assessment
              • 2 animal species, 2 routes of admin
          • Lead optimisation
            • Pharmaco-logical and pharmaco-kinetic optimisation
        • Find target and confirm role in disease
    • Biologics
      • Biological products
        • High molecular weight
        • Made from live cells/ organisms
        • Structure may not be well-defined
        • Hetero-geneous mixture
        • Immunogenic
      • Small molecule drugs
        • Low molecular weight
        • Chemical synthesis
        • Known structure
        • Homo-geneous
        • Usually not immunogenic
      • Proteins
      • Nucleic acids
      • Blood derivates/ components
      • Human tissues/cells
      • Gene therapies
      • Vaccines
      • Antibodies
    • New product submitted for NICE approval
      • Positive NICE approval
        • New product added to formulary
      • Absence of NICE approval
        • Local/regional drug commission groups
          • Exceptional cases panels
          • Product funding may or may not be approved
            • Exceptional cases panels
      • NICE have not approved
      • Economic evaluation
        • Cost-minimisation analysis
          • Assume same efficacy
          • Which is cheapest
        • Cost-effectiveness analysis
          • Factor in efficacy of each treatment
          • (Cost of A-cost of B)/ (effectiveness of A- effectiveness of B)
        • Cost-utility analysis
          • Cost per QALY gained
        • Cost-benefit analysis
          • Also factor in other benefits
          • Rarely used due to difficulty of expressing all benefits in monetary terms

    Comments

    No comments have yet been made

    Similar Medicine resources:

    See all Medicine resources »See all Pharmacology resources »