How should the risk assessment be conducted
- Following existing information.
- using a tiered approach
- using robust and relevant methods
What are 4 goals of risk assessment
- human relevant
- exposure-led
- hypothesis driven
- designed to prevent harm
How should the risk assessment be documented?
- identifying and characterizing sources of uncertainty
- transparent and explicit about logic of overall approach
4 main overriding principles
- human safety risk assessment
- exposureled
- hypothesis driven
- designed to prevent harm
3 principles describe how a NGRA should be conducted
- following existing information
- tiered approach
- relevant methods
2 principles for documenting NGRA
- sources of uncertainty should be characterized
- logic should be transparent
What is tier 0
Identify use scenario, and collect existing info
What does tier 0 allow for?
Allows framing of the areas of investigation
When do you exit tier 0
exit if exposure-based waiving or read-across is appropriate
What is tier 1
Hypothesis formulation for ab initio approach
What is part of tier 1?
Systemic bioavailability, mode of action
When do you exit tier 1?
if internal exposure is sufficiently low or a robust safety decision can be made from the calculated points of departure.
What is tier 2
application of ab initio approach
fully develop an understanding of the biological effects resulting from the exposure scenario presented.
