PHM 351 Exam #1 (Michigan State University, MSU - SS20
PHM 351: Fundamentals of Drug Safety) Questions With
Complete Solutions
ames assay Correct Answers · in-vitro, bacterial cells
· salmonella cells with mutations that make it so they can't
produce histidine - drug is added - grown on plate lacking
histidine - sample with drug grows more plaques
chromosome abberation Correct Answers · in-vitro,
mammalian cells
· cells are cultured in-vitro and exposed to the drug - frequency
of chromosomal disruption is examined
Clinical development Correct Answers · Phase 1 - dose
finding: healthy humans
· Phase 2 - safety & activity: evaluation of response vs dose in
humans with the disease
· Phase 3 - comparative efficacy: confirm effectiveness, identify
adverse effects and long-term toxicology studies, *pre-NDA
meeting*
Discovery Correct Answers · Develop an idea
· Search for new medicine
For what specific adverse effect was the ICH S7B guideline
designed to test? Describe an assay or experiment that examines
this adverse effect. Correct Answers · Prolonged QT intervals
· In-vitro hERG assay - measures ionic current through specific
potassium channel
, How are compounds tested for potential embryonic fetal
development abnormalities? What incident prompted this testing
in 2 species? Correct Answers Tested for:
· Adverse effects of the drug
· Evidence of different sensitivity of the reproductive system
compared to other organs/systems
· Dose relationships
· The thalidomide incident (rodent & rabbit)
How are new animal drug approval regulations different from
human drug approvals? Correct Answers · Drugs used in food-
producing animals require human food safety tests to make sure
drug residues left in the animal tissues are safe for human
consumption
· Environmental impact tests
Identify/name and describe 2 types of in-vitro assays and define
why they are important for drug safety testing? Correct
Answers · Membrane integrity: damaged cells will release
enzymes like lactate dehydrogenase
· Cellular ATP content: dead/damaged cells contain little to no
ATP
· Important to know if the drug is damaging/killing cells
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