Virology Human Clinical Trials

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  • Human clinical trials
    • Phase I
      • Here is the first  trials in man
      • There are a small no. of volunteers, 10-50
      • Single doses giving increasing to higher multiple doses
      • Monitor the drug
        • For adverse effects
        • For pharamocokinetics
        • 40% of drugs fail
      • Northwick Park trials 2006
    • Phase II
      • Small number of patients
        • 50-100
      • IIa
        • Confirming that drug metabolism
        • Is the same as healthy volunteers
      • IIb
        • Compare drug to placebo
          • Using double-blinded trial
          • To observe efficacy
      • 30% of drugs fail
        • Not significantly better compared to placebo
    • Phase III
      • Spectrum of therapeutic benefit:risk
      • More than one phase II trail
      • Large number of patients
        • 1000
      • Randomized double-blind trial
        • Dr doesn't know which is administered
      • Compare against placebo and existing treatment
    • Phase IV
      • Large scale with broad patient population
      • Approved for marketing
        • 90% of these drugs pass phase III
      • Monitored for long term effectiveness
      • Monitored for long term side effects
      • Post-market surveillance
      • Further studies to test drugs in...
        • New age group
        • New patient group

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