The rest of the questions

Question 1

Toxicology is the study of

Answer 1

adverse effects of chemical, physical or biological agents

Question 2

Which key factor(s) can, among others, determine a toxic effect?

Answer 2

Compound, concentration and duration

Question 3

Can toxicodynamics be divided into local and systemic effects?

Answer 3

Yes

Question 4

Toxicokinetics describes

Answer 4

How the body handles a chemical as a function of dose and time

Question 5

The difference in doses between NOAEL in animals and the expected clinical dose in humans is called

Answer 5

The margin of safety

Question 6

What sub-types of toxicities cannot be directly investigated in vitro?

Answer 6

Embryotoxicity

Question 7

What can be the advantages with in vitro toxicology studies?

Answer 7

Cheap, simple and high throughput

Question 8

The Ames test is used for studying

Answer 8

In vitro mutagenicity

Question 9

Cardiotoxicity is not a very crucial parameter in safety assessment. True or false

Answer 9

False

Question 10

Higher tier assays DON’T lead to…

Answer 10

Decreased resources

Question 11

Which method is a part of “New approach Methodologies” (NAMs)

Answer 11

In silico methods

Question 12

What is a part of exploratory toxicology?

Answer 12

Dose range-finding

Question 13

Non-clinical safety studies are…

Answer 13

Able to assess potential unwanted effects of drug candidates

Question 14

Phase 1 of clinical trials indludes patients?

Answer 14

True

Question 15

Size of compound of interest affects testing strategy?

Answer 15

True

Question 16

Off target toxicities are common in..

Answer 16

Toxicity studies of NCEs

Question 17

Immunogenicity to a human product in animals is predictive for immunogenicity in humans?

Answer 17

False

Question 18

Which species are relevant to be used for toxicity studies?

Answer 18

One in which the test materials is pharmacologically active

Question 19

For setting the dose in FHD studies, clinical safety data is evaluated for each step.

Answer 19

True

Question 20

Principles for determining the clinical dose do NOT include

Answer 20

Company’s end goal for the dose

Question 21

Which of these is NOT a strategy to enter FHD trials

Answer 21

TEM

Question 22

What tests can be carried out to evaluate immunotoxicology endpoints?

Answer 22

Cytokine measurements in vivo

Question 23

Why are rabbits the preferred selected species for reprotoxicity studies?

Answer 23

higher numbers of dams and offspring