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1. Phase 2 of the clinical trials process:

A. Includes 20 to 80 patients and the goal is to determine bioequivalence B. Includes 100 to 300 patients and one of the goals is to establish the optimal dose of the drug C. Includes 1000 to 3000 patients and its focus is post-marketing surveillance D. None of the above

2. Approximately how many investigational drugs make it past phase 2 studies?

A. 10% B. 20% C. 30% D. 50%

3. Medication guides (MedGuides):

A. May be part of a REMS program B. Are part of FDA-approved patient labeling for select products C. Should be provided to the patient each time the drug is dispensed in the retail setting, provided the drug has a MedGuide as part of its labeling D. All of the above

4. Afrezza, which was FDA-approved in 2014, is contraindicated in patients with which of the following conditions?

A. Type 1 diabetes B. Type 2 diabetes C. COPD D. High cholesterol

5. Olodaterol is indicated for which of the following conditions:

A. Diabetes B. Myocardial infarction C. COPD D. Erectile dysfunction

6. Naloxegol:

A. Is FDA-approved for the treatment of opioid-induced constipation B. Should be taken on an empty stomach C. Has an FDA-approved MedGuide D. All of the above

7. With regard to the Orange Book's therapeutic equivalence rating system, a product with an AB rating:

A. Requires further FDA evaluation B. Meets necessary bioequivalence standards C. Has documented bioequivalence problems D. None of the above

8. Which of the following statements is correct?

A. OTC products that meet specific drug monograph requirements do not require FDA preapproval B. There is ongoing discussion centered on updating the OTC monograph system C. Manufacturers may request a switch from prescription-only to OTC status D. All of the above

9. Nexium 24HR is approved to treat heartburn that occurs:

A. ≥ 1 day per week B. ≥ 2 days per week C. Nexium is not approved to treat heartburn D. None of the above

10. Patients who have which of the following conditions should consult their doctor before using nasal corticosteroids?

A. Injuries to the nose B. Tuberculosis C. Glaucoma D. All of the above

Evaluation Questions

11. To what extent did the program meet objective #1?

A. Excellent B. Very Good C. Good D. Fair E. Poor

12. To what extent did the program meet objective #2?

A. Excellent B. Good C. Fair D. Poor

13. To what extent did the program meet objective #3?

A. Excellent B. Very Good C. Good D. Fair E. Poor

14. To what extent did the program meet objective #4?

A. Excellent B. Very Good C. Good D. Fair E. Poor

15. Rate the effectiveness of how well the program related to your educational needs:

A. Excellent B. Very Good C. Good D. Fair E. Poor

16. Rate how well the active learning strategies (questions, cases, discussions) were appropriate and effective learning tools:

A. Excellent B. Very Good C. Good D. Fair E. Poor

17. Rate the quality of the faculty:

A. Excellent B. Very Good C. Good D. Fair E. Poor

18. Rate the effectiveness and the overall usefulness of the material presented:

A. Excellent B. Very Good C. Good D. Fair E. Poor

19. Rate the appropriateness of the examination for this activity:

A. Excellent B. Very Good C. Good D. Fair E. Poor

20. Rate the effectiveness of how well the activity related to your practice needs:

A. Excellent B. Very Good C. Good D. Fair E. Poor

21. Rate the effectiveness of how well the activity will help you improve patient care:

A. Excellent B. Very Good C. Good D. Fair E. Poor

22. Will the information presented cause you to change your practice?

A. Yes B. No

23. Are you committed to making these changes?

A. Yes B. No

24. As a result of this activity, did you learn something new?

A. Yes B. No

25. What is your practice setting or area of practice?

A. Community Pharmacy/Independent B. Community Pharmacy/Chain C. Hospital/Health Systems D. Administrative/Pharmacy Director E. Critical Care Pharmacy F. Long-term Care G. Managed Care/PBM H. Oncology/Specialty Pharmacy I. Industry/Manufacturing

26. How many years have you been in practice?

A. <5 B. 5 – 10 C. 11 – 20 D. >20

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