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New drug approval process

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New drug approval process

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

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