PG NEXT Question of the Day 25-10-2016
Question:
Phase 4 clinical trial is also called as
a. Human pharmacology and safety
b. Post marketing surveillance
c. Therapeutic exploration & dose ranging
d. Therapeutic confirmation
Answer: b. Post marketing surveillance
Explanation:
Therapeutic use (post-licensing studies) – Surveillance foe safety and efficacy: further formal therapeutic trials, especially comparisons with other drugs, marketing studies and pharmacoeconomic studies.
Reference:
1. Goodman & Gilman’s The Pharmacological Basis of Therapeutics, 12e, p. 1054
2. Bennett & Brown Clinical Pharmacology, 9e, p.56