Module 2c Flashcards
clinical research
the bridge between the basic research laboratory and the patient’s bedside
clinical testing of experimental drugs are normally done in ___ phases.
three
After successful completion of Phase I-III testing, a company will submit the results of the studies to the FDA to obtain ___.
NDA = New Drug Approval
Phase I testing is primarily concerned with the drug’s ____.
safety
Phase II studies can start once an experimental drug has been proven to be safe and well tolerated in ___ volunteers. It must be tested in the patients that have the
disease or condition that the experimental drug is expected to improve/cure.
healthy
Phase III studies compare the new drug to the ___ treatment
standard
After successful completion of Phase I-III testing, a company submits the results of all of the studies to the FDA to
obtain a:
New Drug Application (NDA)
