Final Exam Mar 2019

4. PHASE III STUDY
5. PROTECTS PATIENTS IN DOUBLE-BLIND TRIAL FROM UNDETECTED SIGNIFICANT SIDE-EFFECTS
7. FDA AGREES TO FULL REVIEW OF NDA OR BLA
8. GENERIC DRUG APPLICATION FOR APPROVAL
12. PATIENT ALERTS FDA OF SUSPICIOUS ACTIVITY AT CLINICAL TRIAL SITE
13. SMALL DRUG MOLECULE THAT BINDS TO A LARGE BIOMOLECULE
15. COMMON STRUCTURE FOR PHASE I TRIAL
16. MAY MARKET DRUG WITH ITS RECEIPT
17. AE OR SAE NOT PREVIOUSLY OBSERVED
19. AN EXPEDITED NDA OR BLA FDA REVIEW
20. PATIENT ACCESSES EFFECTIVE STUDY DRUG BEFORE FDA APPROVAL
23. BIOPHARMA M.D. RESPONSIBLE FOR STUDY SUBJECT SAFETY
26. PERMANENT PROHIBITION FROM PARTICIPATING IN CLINICAL TRIALS UNDER A U.S. IND

1. FDA REPORT ON AN APPROVED DRUG BEING MISTAKEN FOR ANOTHER APPROVED DRUG
2. THE DRUG WORKS!
3. FINAL PRODUCT OF CLINICAL TRIAL FOR AN INVESTIGATIONAL DRUG
6. RESPONSIBLE FOR GENERATING TLGs
9. MAY OR MAY NOT BE CAUSED BY STUDY DRUG
10. POSITIVE RESULT FROM HIGH THROUGHPUT SCREEN
11. MEASUREMENT OF A DRUG’S EFFECTIVENESS IN A CLINICAL TRIAL
14. DRUG’S ABILITY TO PRODUCE A PHARMACOLOGICAL EFFECT AT A GIVEN CONCENTRATION
18. COMPUTER CODE INSTRUCTION THAT AUTOMATICALLY TRIGGERS DATA QUERY
21. PRESCRIBING INFORMATION
22. FORMAT OF IND SAFETY REPORT
24. PHASE Ib CLINICAL TRIAL
25. BIOPHARMA REPRESENTATIVE THAT REGULARLY VISITS CLINICAL STUDY SITE