lecture 1-3 Flashcards
What is an example of a risk assessment?
the nuclear crisis at the power plant in Japan after an earthquake. It was defined as a danger zone for japan, citizens must evacuate within 12 mile radius.
US defined the danger zone to stay 50 miles away from the plant.
What is risk assessment?
a process by which
scientists to evaluate the potential for adverse
health or environmental effects from exposure
to naturally occurring or synthetic agents.
(largely scientifically‐based)
what is risk management?
to develop and execute
the policy to deal with hazards identified
through risk assessment, including the
evaluation of alternative regulatory options.
(in combination of science and administration)
What are the steps that the FDA takes in risk assessment?
Provide the evidence of safety / efficacy.
judge the risk and benefits
identify new risk and seek scientific advice.
examine new risk and provide new technology
when would a substance not need to be reviewed and approved by the FDA?
if it is considered GRAS
what are the steps to risk assessment in FDA in pharmaceuticals?
Drug discovery 2-10 years
Pre clinical research 3-6 years (animal experiments do not have to approved by the FDA. (but ICOOK makes sure it is humane)
Clinical trial 6-7 years - in humans
Phase 1 test in healthy people
Phase 2 study in disease people
Phase 3 Large scale testing in individuals with disease
FDA reviews 1-2 years
Manufacturing
are dietary supplements required for safety tests?
NOPE
What are some consequences of dietary supplements in their risk assemssment?
Generally, manufacturers do not need to register
their products with FDA nor get FDA approval before producing or
selling dietary supplements.
what are the components of risk assessment?
hazard identification,
dose response
exposure
risk characterization
what is the question associated with hazard identification?
is it harmful?
what is the question associated with dose response?
how much to cause harm?
what is the question with exposure assessment?
what is the real exposure?
what is the question associated with risk characterization?
how does it cause the harm, how dangerous is it?
in hazard identification? as conducting research progresses, from structure relationship to human epidemiological data, efficiency ________ and biocomplexity __________.
decreased and increased
Similar to Scoville heat scale,
______________________________ is
the estimate of compound‐
specific toxicity relative to the
toxicity of an index chemical
(such as TCDD).
Toxic Equivalency Factor (TEF)
___ = sum (toxicant)1 x TEFi
TEQ
