Dosage forms exam 1 New drugs

  1. Clinical
    Studies in humans
  2. Drug Development pipeline
  3. Drug Discovery- Preform/biological characterization/initial formulation-IND- Final product/Clinical trials/ Long term toxicity---- NDA
  4. Hit
    Molecule that interacts with targets
  5. Lead
    The best hits that warrant further investigation
  6. Candidate
    The lead most suitable for extensive investiagion
  7. Biological characterization
    Potential for use as therapeutic agent by- pharmacology, toxicology, disposition and pharmacokinetics.
  8. Preforumulation broken into (2)
    • Physicochemical properties
    • Analytic method developement
  9. Physicochemical properties
    pKa, Solubility, Stability
  10. Dosage formulation
    Process of turning an active compound into a form and strength suitable for human use.
  11. Investiagional New Drug Application (IND)
    Must be filed with FDA before human testing
  12. Main purpose of IND
    • 1) Protect rights and safety of the human subjects.
    • 2) Ensure investigational plan is sound
  13. Phase 1 clinical drug trials
    • Mainly safety, 20-100 (usually healthy) patients.
    • 67% pass through takes several months
  14. Phase 2
    • Patients suffering indication
    • several hundred
    • up to two years
    • 45% pass
  15. Phase 3
    • Thousands
    • 1-4 years
    • 5-10% pass
  16. NDA Application
    Integrates all data
  17. cGMP
    Apply to all aspects of pharmaceutical manufacture... all manufacturing facilities are inspected.
  18. Complete response letter
    Application not ready for approval
  19. Phase 4 clinical studies
    Add to the understanding of the drug's effects.
  20. Adverse reaction reporting
    Required by everyone, physicians, postmarketing studies, and pharmacists
  21. IND for rare orphan drugs
    Financial support for clinical trials of these drugs, seven years of exclusive marketing rights.
  22. Treatment protocol
    Filed during phase 1 or 2 to allow treatment of the desperately ill.
  23. Bioavailability
    NDA used for generic drug approval.
  24. Supplemental new drug applicagtion
    required for changes of method of synthesis, formulation, analytical standards, container or manufacturing facilities.
  25. Costs of clinical trials
    Most expensive is NDA submission, least expensive is pre clinical.
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Dosage forms exam 1 New drugs
New drugs for Dosage forms exam 1