The rest of the questions Flashcards
Toxicology is the study of
adverse effects of chemical, physical or biological agents
Which key factor(s) can, among others, determine a toxic effect?
Compound, concentration and duration
Can toxicodynamics be divided into local and systemic effects?
Yes
Toxicokinetics describes
How the body handles a chemical as a function of dose and time
The difference in doses between NOAEL in animals and the expected clinical dose in humans is called
The margin of safety
What sub-types of toxicities cannot be directly investigated in vitro?
Embryotoxicity
What can be the advantages with in vitro toxicology studies?
Cheap, simple and high throughput
The Ames test is used for studying
In vitro mutagenicity
Cardiotoxicity is not a very crucial parameter in safety assessment. True or false
False
Higher tier assays DON’T lead to…
Decreased resources
Which method is a part of “New approach Methodologies” (NAMs)
In silico methods
What is a part of exploratory toxicology?
Dose range-finding
Non-clinical safety studies are…
Able to assess potential unwanted effects of drug candidates
Phase 1 of clinical trials indludes patients?
True
Size of compound of interest affects testing strategy?
True
Off target toxicities are common in..
Toxicity studies of NCEs
Immunogenicity to a human product in animals is predictive for immunogenicity in humans?
False
Which species are relevant to be used for toxicity studies?
One in which the test materials is pharmacologically active
For setting the dose in FHD studies, clinical safety data is evaluated for each step.
True
Principles for determining the clinical dose do NOT include
Company’s end goal for the dose
Which of these is NOT a strategy to enter FHD trials
TEM
What tests can be carried out to evaluate immunotoxicology endpoints?
Cytokine measurements in vivo
Why are rabbits the preferred selected species for reprotoxicity studies?
higher numbers of dams and offspring
