Which of the following is the average length of clinical investigation phase II? ?a. 18 ?months b. 3 ?years c. 5 ?years d. 17 ?years16. ?Which of the following is NOT an advantage of OTC drugs? a. ?They are easily obtained b. ?They are cheaper c. ?They are more effective d. ?They are preferred by patients17. ?Complementary and alternative medicine therapies do NOT use which of the following? a. ?Minerals b. ?Antibiotics c. ?Dietary supplements d. ?Herbs18. ?Herbal and dietary supplements are marketed without approval of which of the following? a. ?NCCAM b. ?DEA c. ?FDA d. ?CFSAN19. ?Which of the following organizations holds an annual meeting to receive patient and health care professional feedback about new drugs? a. ?DEA b. ?FDA c. ?TJC d. ?CDC20. ?How long does it usually take for a full NDA review for a new drug? a. 1 ?year b. 2 ?years c. 3 ?years d. 7 ?years
The Correct Answer and Explanation is :
Let’s address each question with the correct answers and explanations:
16. Which of the following is NOT an advantage of OTC drugs?
- a. They are easily obtained
- b. They are cheaper
- c. They are more effective
- d. They are preferred by patients
Correct Answer: c. They are more effective
Explanation:
Over-the-counter (OTC) drugs offer several advantages:
- a. They are easily obtained: OTC medications are available without a prescription, making them accessible for self-care. (fda.gov)
- b. They are cheaper: OTC drugs are generally less expensive than prescription medications, reducing healthcare costs. (cdn.pfizer.com)
- d. They are preferred by patients: Many patients prefer OTC drugs for minor ailments due to convenience and cost-effectiveness. (chpa.org)
However, c. They are more effective is not necessarily true. OTC drugs are effective for treating minor conditions but may not be suitable for more serious health issues.
17. Complementary and alternative medicine therapies do NOT use which of the following?
- a. Minerals
- b. Antibiotics
- c. Dietary supplements
- d. Herbs
Correct Answer: b. Antibiotics
Explanation:
Complementary and alternative medicine (CAM) therapies often utilize:
- a. Minerals: Used in various forms, such as supplements or in treatments like mineral baths.
- c. Dietary supplements: Includes vitamins, minerals, herbs, and other substances used to enhance health.
- d. Herbs: Herbal remedies are a cornerstone of many CAM practices.
b. Antibiotics are typically not used in CAM therapies, as they are conventional medicines prescribed for bacterial infections.
18. Herbal and dietary supplements are marketed without approval of which of the following?
- a. NCCAM
- b. DEA
- c. FDA
- d. CFSAN
Correct Answer: c. FDA
Explanation:
In the United States:
- a. NCCAM (National Center for Complementary and Integrative Health): Provides research and information on CAM but does not approve supplements.
- b. DEA (Drug Enforcement Administration): Regulates controlled substances but does not approve supplements.
- c. FDA (Food and Drug Administration): Does not approve herbal and dietary supplements before they are marketed. Instead, it monitors them post-marketing for safety and labeling compliance.
- d. CFSAN (Center for Food Safety and Applied Nutrition): A branch of the FDA that oversees dietary supplements.
19. Which of the following organizations holds an annual meeting to receive patient and health care professional feedback about new drugs?
- a. DEA
- b. FDA
- c. TJC
- d. CDC
Correct Answer: b. FDA
Explanation:
The FDA (Food and Drug Administration) holds annual meetings to gather feedback from patients and healthcare professionals regarding new drugs. This engagement helps the FDA understand public concerns and preferences, which can influence drug approval and regulation processes.
20. How long does it usually take for a full NDA review for a new drug?
- a. 1 year
- b. 2 years
- c. 3 years
- d. 7 years
Correct Answer: b. 2 years
Explanation:
The New Drug Application (NDA) review process by the FDA typically takes about 2 years. This period allows the FDA to thoroughly evaluate the safety and efficacy data provided by the drug manufacturer before granting approval.