Risk Assessment (L6)

Question 1

Risk Assessment Process

Answer 1

->Research
-> Risk assessment
-> Risk Management
-> Evaluate consequences
-> Agency decisions and Actions

Question 2

Hazard identification and characterisitics

Answer 2

-> Deduction
-> Observation
-> Experimental work
-> Information
-> Harm type
-> Harm dose

Question 3

What are the three phases of a clinical trial for population sample?

Answer 3

Phase I: Small number of human volunteers/patients
Phase II: Larger number of patients than phase I
Phase III: Large number of patients

Question 4

What are the two phases of a clinical trial trying to find out?

Answer 4

Phase I: information about metabolism/disposition
Phase II: Information about effects/efficacy

Question 5

What system is adversed effects reported throughout?

Answer 5

MHRA: System for reporting AE in the UK; yellow card

Question 6

What are the 4 stages of a full clinical trial?

Answer 6

A) Preclinical testing
B) Clinical research
C) Final data analysis
D) Follow up

Question 7

What are three phases in preclinical testing?

Answer 7

1) Laboratory trials
2) Research protocol
3) Animal testing

Question 8

What occurs during a follow up in clinical trials?

Answer 8

• Therapy proven to be safe and effective
• Approved by medical authorities
• Continuitive testing

Question 9

What is an example of a drug trial going wrong?

Answer 9

2006 testing of drug TGN1412 that passed animal trials

Question 10

What happened in the drug trial for TGN1412 (leukaemia drug)?

Answer 10

• Cytokine release syndrome (CRS) causing multi-organ failure within some of the men
• Six men were in intensive care
• All live with adverse effects

Question 11

Describe what hazard characterisation is

Answer 11

Determing if a chemical is persistent, bioaccumulative and toxic
Developing exposure standards with a maximum safe exposure

Question 12

In vivo testing requires a known dose of the test agent be administered… 1)… 2)

Answer 12

1) in a responsible manner
2) related in possible to the expected route of exposure to humans

Question 13

Name some exposure pathways

Answer 13

• Inhalation
• Surface water pollution
• Ground water pollution
• Air transport
• Ingestion

Question 14

Case study: Medication in the environment

Answer 14

• Human wastes
• Disposal of unwanted drugs
• In manufacture
• Veterinary

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