Clinical trails


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Clinical trails

  2. 2. 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
  3. 3. 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
  4. 4. How to get permission for CT Data of safety needs to be submitted Protocol need to submitted Strategy and planning need to submit
  5. 5. 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)
  6. 6. Preclinical trailsObjectives To evaluate the toxicity and safety of drug To interpret Initial tolerance level in to the human
  7. 7. 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
  8. 8. Phase 1 trail On the healthy 10-20 healthy volunteers First time dealing with human
  9. 9. 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
  10. 10. 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
  11. 11. Phase 2 First time we introduce drug to pateint Normally 100-200 patients are taken for trail Conducted in OPEN manner
  12. 12. 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
  13. 13. Phase 3 Comparatively longer time require than phase 2 Normally up to 1000 volunteers are taken for conducting trail
  14. 14. 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
  15. 15. Phase 4 No specific planning 5000-10,000 patient are taken for trail Some rare problems may came out
  16. 16. 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