Final Exam Mar 2019

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Across
  1. 4. PHASE III STUDY
  2. 5. PROTECTS PATIENTS IN DOUBLE-BLIND TRIAL FROM UNDETECTED SIGNIFICANT SIDE-EFFECTS
  3. 7. FDA AGREES TO FULL REVIEW OF NDA OR BLA
  4. 8. GENERIC DRUG APPLICATION FOR APPROVAL
  5. 12. PATIENT ALERTS FDA OF SUSPICIOUS ACTIVITY AT CLINICAL TRIAL SITE
  6. 13. SMALL DRUG MOLECULE THAT BINDS TO A LARGE BIOMOLECULE
  7. 15. COMMON STRUCTURE FOR PHASE I TRIAL
  8. 16. MAY MARKET DRUG WITH ITS RECEIPT
  9. 17. AE OR SAE NOT PREVIOUSLY OBSERVED
  10. 19. AN EXPEDITED NDA OR BLA FDA REVIEW
  11. 20. PATIENT ACCESSES EFFECTIVE STUDY DRUG BEFORE FDA APPROVAL
  12. 23. BIOPHARMA M.D. RESPONSIBLE FOR STUDY SUBJECT SAFETY
  13. 26. PERMANENT PROHIBITION FROM PARTICIPATING IN CLINICAL TRIALS UNDER A U.S. IND
Down
  1. 1. FDA REPORT ON AN APPROVED DRUG BEING MISTAKEN FOR ANOTHER APPROVED DRUG
  2. 2. THE DRUG WORKS!
  3. 3. FINAL PRODUCT OF CLINICAL TRIAL FOR AN INVESTIGATIONAL DRUG
  4. 6. RESPONSIBLE FOR GENERATING TLGs
  5. 9. MAY OR MAY NOT BE CAUSED BY STUDY DRUG
  6. 10. POSITIVE RESULT FROM HIGH THROUGHPUT SCREEN
  7. 11. MEASUREMENT OF A DRUG’S EFFECTIVENESS IN A CLINICAL TRIAL
  8. 14. DRUG’S ABILITY TO PRODUCE A PHARMACOLOGICAL EFFECT AT A GIVEN CONCENTRATION
  9. 18. COMPUTER CODE INSTRUCTION THAT AUTOMATICALLY TRIGGERS DATA QUERY
  10. 21. PRESCRIBING INFORMATION
  11. 22. FORMAT OF IND SAFETY REPORT
  12. 24. PHASE Ib CLINICAL TRIAL
  13. 25. BIOPHARMA REPRESENTATIVE THAT REGULARLY VISITS CLINICAL STUDY SITE