Lecture 3 Flashcards

1
Q

How should the risk assessment be conducted

A
  1. Following existing information.
  2. using a tiered approach
  3. using robust and relevant methods
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2
Q

What are 4 goals of risk assessment

A
  1. human relevant
  2. exposure-led
  3. hypothesis driven
  4. designed to prevent harm
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3
Q

How should the risk assessment be documented?

A
  1. identifying and characterizing sources of uncertainty
  2. transparent and explicit about logic of overall approach
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4
Q

4 main overriding principles

A
  1. human safety risk assessment
  2. exposureled
  3. hypothesis driven
  4. designed to prevent harm
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5
Q

3 principles describe how a NGRA should be conducted

A
  1. following existing information
  2. tiered approach
  3. relevant methods
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6
Q

2 principles for documenting NGRA

A
  1. sources of uncertainty should be characterized
  2. logic should be transparent
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7
Q

What is tier 0

A

Identify use scenario, and collect existing info

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8
Q

What does tier 0 allow for?

A

Allows framing of the areas of investigation

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9
Q

When do you exit tier 0

A

exit if exposure-based waiving or read-across is appropriate

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10
Q

What is tier 1

A

Hypothesis formulation for ab initio approach

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11
Q

What is part of tier 1?

A

Systemic bioavailability, mode of action

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12
Q

When do you exit tier 1?

A

if internal exposure is sufficiently low or a robust safety decision can be made from the calculated points of departure.

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13
Q

What is tier 2

A

application of ab initio approach
fully develop an understanding of the biological effects resulting from the exposure scenario presented.

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