Clinical trails
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Clinical trails

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Clinical trails Clinical trails Presentation Transcript

  • CLINICAL TRAILS
  • WHAT IS CLINICAL TRAIL? Clinicaltrail are the trails in which safety and tolerance limit of the drug is evaluated in to the animal or in the human being
  • Why the clinical trails necessary Clinical trails are necessary for decreasing the mortality rate of the human due to unexpected toxicity of the newer molecule It has been told that if we omit the phase of the clinical trails than the total population of the world will be half of the current population
  • How to get permission for CT Data of safety needs to be submitted Protocol need to submitted Strategy and planning need to submit
  • Various phases of CT Preclinical trail ( in animal) Phase 1 (on healthy human volunteers) Phase 2 (on patient) Phase 3 (on patients and special population also) Phase 4 (Post marketing surveillances)
  • Preclinical trailsObjectives To evaluate the toxicity and safety of drug To interpret Initial tolerance level in to the human
  • Preclinical trailsStudies carried out at preclinical trail phase Development of the methodology for quantification of drug in plasma Mass balance-metabolite profile PK monitoring PK-PD relation Long term toxicity Protein binding Tissue distribution Placental transfer kinetic
  • Phase 1 trail On the healthy 10-20 healthy volunteers First time dealing with human
  • Phase 1 trailObjectives Determine the tolerability and acute toxicity Characterize PK (single and multiple dose) Dose-concentration-effect or toxicity relation To check Suitability of animal model Evaluate bioavailability
  • Phase 1 trailTypes of study Dose- concentration-effect or toxicity relationship (checking for linearity ) IV single-dose study Radio active tracer study for study mass balance Evaluation of suitability of animal model Evaluation of drug formulation Effect of food Special population
  • Phase 2 First time we introduce drug to pateint Normally 100-200 patients are taken for trail Conducted in OPEN manner
  • Phase 2Objectives For define most effective dose Collect the additional safety and PK data To check the difference in PK and PD in healthy volunteers and patient Careful monitoring more than one therapeutic or toxicity end point
  • Phase 3 Comparatively longer time require than phase 2 Normally up to 1000 volunteers are taken for conducting trail
  • Phase 3Objectives To identify less common side effect Comparison with standard therapy Study in special population Long term safety Long term effectiveness Study different dosage regimen Closer inspection of the drug interaction For developing the drug with multiindication
  • Phase 4 No specific planning 5000-10,000 patient are taken for trail Some rare problems may came out
  • Drug labeling To advice the prescriber regarding the safe and effective use o the drug To individualized the drug therapy Gives information to clinician for choosing the correct dose for individual patient