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Clinical trials for product developement

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clinical trials for product development

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Clinical trials for product developement

  1. 1. CLINICAL TRIALS FOR PRODUCT DEVELOPEMENT Speaker: MADIHAAHMED 11761 BUSHRA KHAN 11742
  2. 2. CLINICAL TRIALS : A research activity that involves administration of a test treatment to some experimental unit in order to evaluate the treatment. Clinical Trials
  3. 3. Clinical Trials • Clinical trials are conducted only when, -Satisfactory information has been gathered on the quality of the nonclinical safety. - Health authority/ethics committee approval is granted in the country where approval of the drug is sought. • Clinical Trial is the mainstay for bringing out New Drugs to the Market.
  4. 4. Drug Review Steps  Preclinical (animal) testing.  An investigational new drug application (IND) : outlines what the sponsor of a new drug proposes for human testing in clinical trials.  Phase 1 studies  Phase 2 studies  Phase 3 studies  Submission of New Drug Application (NDA) is the formal step asking the FDA to consider a drug for marketing approval. FDA reviewers will approve the application or find it either "approvable" or "not approvable.“  Phase 4 studies DRUG REVIEW STEPS : Preclinical Data IND Filing IND Approval Phase I Phase II Phase III NDA Filed NDAApproval Marketing Permission Phase IV DCGI Mandatory Approval Points Sponsor Go/No Go Decision Points
  5. 5. CPD-Phases CLINICAL PRODUCT DEVELOPMENT- PHASES:
  6. 6. Clinical Trials Major areas are: • Pharmacodynamic studies in vivo in animals, In vitro preparation • Absorption, distribution , elimination studies (pharmacokinetics) • Acute ,sub acute, chronic toxicity studies (toxicity profile) • Therapeutic index (safety & efficacy evaluation) PRECLINICAL TRIAL :
  7. 7. Phases Of Clinical Trials  Focused on tolerability and safety.  12-30 (150) healthy people (often males).  Efficacy on biomarkers .  Single and repeated doses.  Increase dose levels.  Interaction with other drugs.  Pharmacokinetics.  Explorative. Phase I 50-150 people Phase II 100-200 people Phase III 500-15000 people Phase IV studies continue PHASE 1 TRIAL :
  8. 8. Phases Of Clinical Trials Phase I 50-150 people Phase II 100-200 people Phase III 500-15000 people Phase IV studies continue PHASE 2 TRIAL :  50-1000 patients.  Extensive monitoring.  Safety and tolerability in patients.  Often complicated design, explorative.  Selection of optimal dose.  Pharmacokinetics in patients.  Effect in special populations.  Explorative.
  9. 9. Phases Of Clinical Trials Phase I 50-150 people Phase II 100-200 people Phase III 500-15000 people Phase IV studies continue PHASE 3 TRIAL :  500-15000 patients  Effect is verified in the target population  Forms the basis of the NDA, New Drug Application  Interactions between drugs start to become measurable in the larger population  Sub-groups start to be established  Special features and problems show up  Confirmative
  10. 10. Phases Of Clinical Trials Phase I 50-150 people Phase II 100-200 people Phase III 500-15000 people Phase IV studies continue PHASE 4 TRIAL :  Often large 500-15000 patients  Further investigation of efficacy and safety post approval  Special populations  New indications  Marketing
  11. 11. Correlation

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