US RAC Review Questions RAPS Modules

US RAC Review Questions RAPS Modules
Question 1: In which situation is an IND not required?
A) You intend to conduct a clinical trial with an investigational
new drug
B) You intend to conduct a clinical trial with an approved drug
to support a marketing application for a new indication
C) You intend to collect blood samples from subjects to look for
biomarkers or pharmacogenetic information
D) You intend to conduct a clinical trial using 2 of your
approved drugs in a new combination
CORRECT ANSWER: C) You intend to collect blood samples
from subjects to look for biomarkers or pharmacogenetic
information
---
Question 2: In the clinical development plan for an
investigational antihypertensive drug, which of the following
studies would typically be conducted first:
A) 1 month repeat dose toxicology study
B) Single dose escalation PK study in healthy volunteers

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