Deck 4: Drug Development, Regulation, and Prescription Writing

Question 1

The following characterizes Phase 3 trials of drug development:

A) Conducted on several thousand patients with specific diseases to determine overall risk-benefit relationships
B) Conducted on a small number of normal volunteers to determine safe dosage range and pharmacokinetic parameters
C) Conducted on animals to determine what potential toxicities exist and at what serum levels those toxicities are manifest
D) Surveillance of a drug after release on the market to determine whether any previously undetected side effects develop after extended use of the drug on large populations
E) Conducted on several hundred patients with specific diseases to determine short-term safety and effectiveness of the drug

Answer 1

Conducted on several thousand patients with specific diseases to determine overall risk-benefit relationships

Question 2

Which of the following pairs of Latin abbreviations and English meanings is correct?

A) QID = daily
B) AC = after meals
C) PO = by mouth
D) BID = every 2 days
E) = with

Answer 2

PO = by mouth

Question 3

In the United States, a "rare disease" is defined as one affecting fewer than what number of people?

A) 25,000
B) 50,000
C) 100,000
D) 200,000
E) 400,000

Answer 3

200,000