Definitions

Question 1

Define what a ‘risk’ is.

Answer 1

Probability of an adverse effect in an organism, system or population caused under specified circumstances by exposure to an agent.

Question 2

Define a Risk Assessment.

Answer 2

Process to calculate or estimate the risk of a given target organism, system or population after exposure to a particular agent.

After taking into account characteristics of the agent and the characyerisitics of the target system.

Question 3

Define a ‘hazard’.

Answer 3

The inherent property of a material that has the potential to cause an adverse of harmful effect when an organism, system or sub-population is exposed to that agent.

Question 4

What does MABEL stand for?

Answer 4

Minimal Anticipated Biological Effect Level

Question 5

What does NOAEL stand for?

Answer 5

No Observable Adverse Effect (Level)

• Greatest amount by experiment which causes NOAEL on morphology, development, life span, etc

Question 6

What is MABEL?

Answer 6

Anticipated dose needed to result in a biological effect in participants of a clinical trial
- Safety window based on pharmalogical threshold

Question 7

What does LOAEL stand for?

Answer 7

Lowest Observable Adverse Effect Level

• lowest concentration or amount of substance which can cause adverse effects from normal organisms of the same species under same defined conditions of expososure

Question 8

What does BMD stand for?

Answer 8

Bench Mark Dose

Lowest confidence limit of dose calculated to be associated with a given incidence of effect estimated from the data

Question 9

What does “In vivo” mean in testing?

Answer 9

Refers to when research or work is done with or within an entire, living organism. Examples can include studies in animal models or human clinical trials.

Question 10

Define metabolism

Answer 10

The process by which a drug is converted into a form that can its elimination from the body

Irreversible biochemical transformation into metaboltes from a drug