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New drug approval process

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  • 1. New Drug Approval Process FDA CDER (Center for Drug Evaluation and Research) Clinical Trials
  • 2. Reasons for Medication Use
    • Prevention
      • Vaccines
      • Antimalaria agents
      • Antibiotic prophylaxis
    • Curative
      • Antibacterial
      • Oncology drugs
      • Antifungal
    • Control of Disease Process
      • Antihypertensives
      • Antidiabetics
      • Thyroid agents
    • Palliation
      • Analgesics
      • Oncology drugs
  • 3. Developing New Medicines Overview
  • 4.  
  • 5.  
  • 6.  
  • 7. Clinical Trials
    • 10-15 years from lab to US patients
    • Only 1 in 5000 compounds make it to human testing
    • Only 1 in 5 tested in humans is approved
    • Testing Phases in Humans
      • DISCOVERY
      • Phase I RESEARCH
      • Phase II DEVELOPMENT
      • Phase III CLINICAL STUDIES
      • Phase IV MEDICINE APPROVED
  • 8. Discovery/Pre-Clinical Testing
    • Laboratory & animal studies
    • Assess safety, biological activity (if any) MOA and formulations
    • 5,000 compounds evaluated
    • 6.5 years
  • 9. PHASE I (file IND )
    • Years 2-4
    • Human healthy male volunteers 20-100
    • Determine safety and dosage
    • Pharmacokinetics
      • Absorption
      • Distribution
      • Metabolism
      • Elimination
    • 5 compounds enter trials
  • 10. PHASE II
    • Years 2-6
    • Patient volunteers 100-500
    • Treat pts for disease for which drug is intended
      • Evaluate side effects & effectiveness
      • Pharmacodynamics
    • Determine dose response curve
  • 11. Phase III
    • Years 3-6
    • Patient volunteers 1000-5000
    • Double blind placebo controlled trial
      • Confirm effectiveness monitor adverse reactions from long-term use
    • Special Studies
  • 12. FDA Phase IV
    • File NDA at FDA
    • Review process & approval (or not)
    • Year 1 or more
    • Post Marketing Surveillance ongoing
    • Additional testing as required by the FDA
    • Continuous monitoring of drug in public use
  • 13. 11-12 yr left on patient Medication Available to patients
  • 14.  
  • 15. Generic Medications
    • Patient on parent agent
    • Hatch-Waxman Act 1984
    • Pharmaceutical Co
      • ANDA filed with FDA
        • Bioequivalent
        • Labeling Review
    • Pharmaceutically equiv.
    • Therapeutically equiv.
  • 16.
    • Atomic(molecular) composition
    • Chemical Name
    • Structural Formula
    • Code Number
    • Nonproprietary Name (generic)
      • Stems & classes
        • Therapeutic class
    • Proprietary Name (brand)
    • NDC #
    What’s in a Name?~~
  • 17. The Name Game
    • Power letters
      • PR > PRO
      • Positive
      • ‘ plosive (p,t,k,c)
      • ‘ fricatives (x,z)
      • A>C>P>L>D>Z
    • Palindromes
      • Xanax,Lozol
    • Anagrams
      • Lariam
    • Suffixes
      • Ette,esse,elle
    • Musical
      • Concerta,Sonata, Allegra
    • CLUES:
      • If plan A fails?
      • Vigor at Niagra Falls
  • 18. Similar Names Error Reduction
    • Accuracy
    • Identifying forms
    • Bupropion Buspirone
    • Clomiphene Clomipramine
    • Doxepin Doxidan
    • Halciononide Halcion
    • Lisinopril Fosinopril
    • Prednisone Prednisolone
    • Testoderm Estroderm
    • Zofran Zoloft
    • Triple check your work
    • Verify data entry before processing
    • Do a mental check on dosage
    • Keep work area clutter free
    • Clarify all orders
    • Fill by NDC# & scanner (if applicable)
  • 19. Summary Slide
    • Reasons for Medication Use
    • Clinical Trials
      • Pre Clinical
      • Phase I-IV
    • Generic Medications
    • Preventing Prescription Errors

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