Clinical trials are conducted in phases to evaluate the safety and efficacy of new drugs. Phase 1 trials involve 10-20 healthy volunteers to determine toxicity and pharmacokinetics. Phase 2 trials involve 100-200 patients to identify effective doses and further evaluate safety. Phase 3 trials involve up to 1000 volunteers to study less common side effects, compare to standard treatments, and evaluate long-term safety and effectiveness. Phase 4 trials monitor drugs after approval in 5000-10,000 patients to identify rare or long-term issues.

1. CLINICAL TRAILS

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. 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. How to get permission for CT
 Data of safety needs to be submitted
 Protocol need to submitted
 Strategy and planning need to submit

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. Preclinical trails
Objectives
 To evaluate the toxicity and safety of drug
 To interpret Initial tolerance level in to the
human

7. Preclinical trails
Studies 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. Phase 1 trail
 On the healthy 10-20 healthy volunteers
 First time dealing with human

9. Phase 1 trail
Objectives
 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. Phase 1 trail
Types 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. Phase 2
 First
time we introduce drug to pateint
 Normally 100-200 patients are taken for trail
 Conducted in OPEN manner

12. Phase 2
Objectives
 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. Phase 3
 Comparatively longer time require than
phase 2
 Normally up to 1000 volunteers are taken for
conducting trail

14. Phase 3
Objectives
 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. Phase 4
 No specific planning
 5000-10,000 patient are taken for trail
 Some rare problems may came out

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