Toxicology Exam 2 with 100% Correct
Solutions
While animal testing was historically the primary method used in testing for toxicity,
modern testing methods prefer which type? - correct Answer-In silico, in vitro, and
refined animal testing
In testing a pharmaceutical to comply with FDA requirements, the initial testing consists
of what? - correct Answer-non-clinical laboratory studies
What is the primary goal of a Phase 1 clinical investigation? - correct Answer-to obtain
information to design more definitive Phase 2 clinical investigations.
Determining the overall risk versus the benefit of a new pharmaceutical is part of what?
- correct Answer-Phase 3 clinical investigation
The type of epidemiology study in which individuals are identified according to exposure
and followed to determine subsequent disease risk is known as what kind of study? -
correct Answer-cohort study
An epidemiological study in which the individuals that make up the test cohort are
identified according to past exposures is known as what kind of study? - correct
Answer-retrospective cohort study
Define Risk - correct Answer-the probability that a hazard will occur under specific
conditions
In the risk assessment process ,what happens during the hazard identification step? -
correct Answer-characterization of innate adverse toxic effects of agents
What are the phases of the risk-based decision-making framework proposed by the co-
authors of the "silver book?" - correct Answer-enhanced problem formulation and
scoping, planning and assessment, and risk management
What are modern approaches to hazard identification based on? - correct Answer-
Computer models like (Q)SAR
Adverse Outcome Pathways (AOPs) are methods of hazard identification that ____. -
correct Answer-Evaluate changes in normal cellular signaling pathways using human-
relevant cells of tissues
, Can quantitative read-across be used to determine the value of an endpoint, such as
dose response relationship? - correct Answer-Yes
What do the procedures used to extrapolate from high to low doses depend on? -
correct Answer-Carcinogenicity of the substance
According to EPA, a substance is classified as likely to be carcinogenic to humans
when what is present? - correct Answer-Evidence is adequate to demonstrate potential
carcinogenicity to humans, but not strongly enough to definitively classify as
carconigenic.
What is the primary cancer risk assessment model used by the EPA known as? -
correct Answer-Linearized Multistage Model (LMS)
The Acceptable Daily Intake is calculated by what? - correct Answer-Dividing NOAEL by
safety factors
Animal doses must be converted to human dose equivalents for risk assessment. When
doing this, toxicologists and risk assessors must do what? - correct Answer-Ensure they
use the conversion method mandated or recommended by the regulatory agency most
relevant to their efforts.
Minimal Risk Levels (MRLs) are derived by: - correct Answer-Similarly to deriving the
RfD, but with potentially lower uncertainty factor
What is the major component of exposure assessment involve? - correct Answer-
identifying the exposure pathways
The movement of substances in environmental media is primarily predicted by what? -
correct Answer-using exposure models to derive scientific estimates
An increased cancer risk of 2x 10^-6 means what? - correct Answer-it is likely that
2/million will develop the specific type of cancer in their lifetime due to exposure to the
chemical
Exposure standards are ___. - correct Answer-legally enforceable acceptable exposure
levels or controls
Exposure guidelines are ___. - correct Answer-recommended maximum exposure
levels which are voluntary and not legally enforceable
Consumer exposure standards are developed for hazardous substances and articles by
what group? - correct Answer-U.S. Consumer product safety commission (CPSC)
Who recommends guidance for exposure standards for pharmaceuticals? - correct
Answer-U.S. Food and Drug administration (FDA)
Solutions
While animal testing was historically the primary method used in testing for toxicity,
modern testing methods prefer which type? - correct Answer-In silico, in vitro, and
refined animal testing
In testing a pharmaceutical to comply with FDA requirements, the initial testing consists
of what? - correct Answer-non-clinical laboratory studies
What is the primary goal of a Phase 1 clinical investigation? - correct Answer-to obtain
information to design more definitive Phase 2 clinical investigations.
Determining the overall risk versus the benefit of a new pharmaceutical is part of what?
- correct Answer-Phase 3 clinical investigation
The type of epidemiology study in which individuals are identified according to exposure
and followed to determine subsequent disease risk is known as what kind of study? -
correct Answer-cohort study
An epidemiological study in which the individuals that make up the test cohort are
identified according to past exposures is known as what kind of study? - correct
Answer-retrospective cohort study
Define Risk - correct Answer-the probability that a hazard will occur under specific
conditions
In the risk assessment process ,what happens during the hazard identification step? -
correct Answer-characterization of innate adverse toxic effects of agents
What are the phases of the risk-based decision-making framework proposed by the co-
authors of the "silver book?" - correct Answer-enhanced problem formulation and
scoping, planning and assessment, and risk management
What are modern approaches to hazard identification based on? - correct Answer-
Computer models like (Q)SAR
Adverse Outcome Pathways (AOPs) are methods of hazard identification that ____. -
correct Answer-Evaluate changes in normal cellular signaling pathways using human-
relevant cells of tissues
, Can quantitative read-across be used to determine the value of an endpoint, such as
dose response relationship? - correct Answer-Yes
What do the procedures used to extrapolate from high to low doses depend on? -
correct Answer-Carcinogenicity of the substance
According to EPA, a substance is classified as likely to be carcinogenic to humans
when what is present? - correct Answer-Evidence is adequate to demonstrate potential
carcinogenicity to humans, but not strongly enough to definitively classify as
carconigenic.
What is the primary cancer risk assessment model used by the EPA known as? -
correct Answer-Linearized Multistage Model (LMS)
The Acceptable Daily Intake is calculated by what? - correct Answer-Dividing NOAEL by
safety factors
Animal doses must be converted to human dose equivalents for risk assessment. When
doing this, toxicologists and risk assessors must do what? - correct Answer-Ensure they
use the conversion method mandated or recommended by the regulatory agency most
relevant to their efforts.
Minimal Risk Levels (MRLs) are derived by: - correct Answer-Similarly to deriving the
RfD, but with potentially lower uncertainty factor
What is the major component of exposure assessment involve? - correct Answer-
identifying the exposure pathways
The movement of substances in environmental media is primarily predicted by what? -
correct Answer-using exposure models to derive scientific estimates
An increased cancer risk of 2x 10^-6 means what? - correct Answer-it is likely that
2/million will develop the specific type of cancer in their lifetime due to exposure to the
chemical
Exposure standards are ___. - correct Answer-legally enforceable acceptable exposure
levels or controls
Exposure guidelines are ___. - correct Answer-recommended maximum exposure
levels which are voluntary and not legally enforceable
Consumer exposure standards are developed for hazardous substances and articles by
what group? - correct Answer-U.S. Consumer product safety commission (CPSC)
Who recommends guidance for exposure standards for pharmaceuticals? - correct
Answer-U.S. Food and Drug administration (FDA)
