Unit VI Case StudyAnimal use in toxicity testing has long been .docx

Unit VI: Case Study
Animal use in toxicity testing has long been a controversial
issue; however, there can be benefits. Read “The Use of
Animals in Research,” which is an article that can be retrieved
from http://www.toxicology.org/pubs/docs/air/AIR_Final.pdf.
Evaluate the current policies outlined in the Position Statement
on page 5 of the article. Use the SOT Guiding Principles in the
Use of Animals in Toxicology to guide you in your analysis.
Feel free to use additional information and avenues of
information, including the textbook, to critically analyze this
policy.
In addition, answer the following questions:
adverse health effects?
e information apply to what you are learning in
the course?
Finally, include whether or not you agree with the Society of
Toxicology's position on animal testing.
Your Case Study assignment should be three to four pages in
length. Use APA style guidelines in writing this assignment,
following APA rules for formatting, quoting, paraphrasing,
citing, and referencing.
Adventure Works Marketing Plan
Centralizing Medical Information To Improve Patient Care
(
Centralizing Medical Information To Improve patient Care
)

Contents
Centralizing Medical Information To Improve patient Care0
Contents1
History2
Executive Summary2
High-Level Functional Requirements:4
Project Charter4
Business Problem Statement5
Project Scope5
Budget and Schedule6
Strategy6
SWOT ANALYSIS6
Technology Constraints7
Project Documentation and Communication9
Project Organization and Staffing Approach9
Project Value Statement9
History
The Affordable Care Act law was passed to improve healthcare
for its citizens in the United States by increasing the people that
have health insurance and by decreasing healthcare cost. A
benefactor to this law is the Medicare/Medicaid program which
provides medical coverage to the poor, elderly and disabled
individuals which is funded by the federal government. The
Federal government covers funding for Medicare programs
while it provides reimbursement funds for Medicaid programs
provided by the states. (The National Federation Of Independent
Business V Sebellius, Secretary Of Health And Human Services,
2012). The primary benefits of the Affordable Care Act Law
are covering more consumers with improved quality of services
while reducing healthcare cost, access to healthcare, and
consumer protection. (ASPA, 2014) Centers For Medicare and

Medicaid Services (CMS) manages both of these programs and
by modernizing and strengthening the current system they will
be lowering cost and providing quality care. Executive
Summary
The Center for Medicare and Medicaid (CMS) is the federal
office to organized the integration of Medicaid and Medicare
services across multiple agencies nationwide. Its purpose is to
improve access to services, improve coordination of services,
and improve cost of services. Medical services cost billions of
dollars to both the state and federal government; therefore,
lowering the cost of these entities while providing valuable and
improved services serves its mission. In complying with the
mission of CMS, our team will provide a centralized database
solution that will solve the following business problems:
· Efficient access to patient medical information by emergency
personnel
· Integrated access to vital medical history and medication
· Patient access to their health record
· Decrease duplication of test by doctors
· Reduce fraud
· Improve patient care
· Reduce medical cost
· Improve patient outcome(About the Medicare-Medicaid
Coordination Office, 2015)
The table below Figure 1 shows Medicare/Medicaid spending
with and without reform and shows that with reform, great
savings can be accomplished over time with cost savings
measures such as the a centralized database.
Figure 1
The new system will provide the following functionalities:
High-Level Functional Requirements:
· Automation of process for maintaining medical records:
1. Access medical information through Pin Number.
1. Provide access of medical information within health care

facilities.
1. Access medical information from scanning health card via
magnetic strip, or barcode
1. Information that can be accessed could include known
allergies, current and past medical conditions.
1. Provide secure way of accessing information, i.e. encryption.
1. Provide for the ability to update and add information in real
time.
1. Granting appropriate permissions to Doctors, Paramedics,
Patients, etc.
1. Patient authorizes medical personnel access to medical
records per HIPAA regulations.
1. Track prescription via medications paid for by Medicaid
insurance
High-Level Proposed
Solution
and Business Benefits
· The solution for this type of system is barcode or magnetic
strip on insurance cards which would retrieve patient medical.
· When scanned, important medical information will be readily
available to doctors or emergency personnel.
· This information can then be linked to a centralized database
for all hospitals which would be housed by government
entityProject Charter
Project Name
Centralizing Medical Information To Improve Patient Care
Prioritization

High
Project Manager(s)
Christine Newton, Trevor Wilks, Anthony Robles, Dhavel Patel
Start Date
January 13, 2016
Owner(s)
CMS
Start Date
February 28, 2016
Project Objectives
The objective is to reduce cost while improving patient care by
providing access to vital medical information to the
stakeholders that need it.Project Conception
The database will provide input via magnetic strip, updates will
be done by medical personnel by scannerBusiness Problem
StatementThe American Recovery and Reinvestment Act of
2009 were established to interoperable health information
technology and qualified electronic health records. Doctors and
patients need accurate information to improve the outcome of
medical care for proper diagnosis and patients need access to
their information regardless of the doctor they choose to visit.
The solution to this is a centralized national database system
which makes diagnosis and treatment easier for doctors and

patients. The centralized database system would allow the
focus on patient care instead of the monetization of the care by
providing vital medical information necessary to expedite
diagnosis. Accurate medical history and quick access to this
information is a vital part of patient care for emergency which
could save lives, provide medical advances with data analysis
and increased diagnosis efficiency. An infrastructure to allow
health information exchange between non-affiliated hospitals
that participate in Medicaid/Medicare which would allow
privacy, provide critical information and improve efficiency
would provide this solution.
Project Scope
The scope of this project is to provide a centralized database
that will serve the following purposes based on the mission and
vision of CMSwhich is to improve patient care while reducing
cost:
· Access to vital medical informationin an emergency
· Access to medication historyby doctors, patients and
emergency personnel
· Access of medical history for patients via pin
· Updated medical information via doctor’s offices
· Access to centralized database via insurance card bar
codeBudget and Schedule

Gant chart goes here
Project Vision
The vision of this project is to provide a comprehensive
centralized database system that will provide vital information
that will improve health service while reducing cost affecting a
wide adaptation that will save lives, provide analysis for
improved medical care, improve patient outcome and drastically
reduce medical cost.StrategySWOT ANALYSIS
Strength
Weaknesses
Opportunities
Threats
HIPPA
Budget
Continuous Updates
Business Constraints:
· HIPPA requirements will require the system to protect all
patient information that is communicated through documents,

verbal communication, electronic communication and any other
methods of communication.
· Budget constraints for Federal funding – Implementation of
the system to be federally approved to work with Affordable
Care Act.
· Web Application will require hospitals to update patient
information continually to reflect current medical history
· Patients will have to actively verify their health information is
current and accurate.Technology Constraints
The technology used for the new system will rely on the latest
available in computing technology and software development
advancements.
· The system is to be accessed through web application
available on workstations, Laptops and mobile devices
· Software development of new system to integrate with existing
electronic medical record systems
· Security of the system will be paramount to ensure compliance
of HIPAA: Web Application, Database, Active storage and Data
at Rest
· Strong Encryption Standards will need to be applied AES 256
at minimum; requiring processing and computing strength
· Integration of multiple OS, architecture, mobile devices –
Windows 7, 8RT, 8.1, 10, Linux, MAC OS, Android, Windows
Phone, Apple Phone
· Track changes to medical records and identify who made the

changes (may require digital certificate for non-repudiation)
· Setting permissions for create/read/modify/delete/view for
users to update patient medical records.
· Medicare/Medicaid insurance cards will need to be updated to
Smart Card with magnetic strips, barcodes or microchips
The Central Medical Information System to Improve Patient
Care is to eliminate the issue of emergency medical personnel
from having to guess what medical conditions, allergies, current
medications or major health issues a patient may have. The
system is to provide this necessary medical information should
the patient be unconscious, unable to speak for themselves or
having to rely on family members not having the most updated
medical history. The Medicare/Medicaid insurance smart card
will be scanned by medical staff to view pertinent patient
information to save lives in emergency situations. The
information will be updated by medical doctors providing
treatment. The system will be available through web
application and mobile application to provide availability
regardless of location or hospital used.Project Documentation
and Communication
The focus of this section is to outline documentation guidelines
as it pertains to the project of centralizing medical information.
The goal is to document and communicate the core of the
project which includes the project objectives and deliverables
and to ensure the project requirements have been met. The

project documentation will capture, share, and communicate
important details and plans to ensure all team members are on
target as well as provide the customer important information for
decision making. Documentation will consist of status reports
to confirm what has been accomplished as well as any potential
issues that could affect the overall delivery. Project
communication will consist of processes that will outline
information distribution as well as performance measurement
methods. It will be a coordinated effort through email and team
meetings as well as mobile technology such as Google
Hangouts.Project Organization and Staffing Approach
The project organization and staffing approach will be
structured around the project activities. The goal of project
organization is to nurture collaboration and interactions of all
those involved in the project as well as promote communication.
Extended goals will be to identify member roles in the project
as well as define the terms at which they will perform in their
respective roles. The staffing approach will consist of
resources for the delivery of the project deliverable. The
staffing approach will include existing team members to better
align the project strategy and goals.Project Value Statement
It is a fact that almost all individuals have a very large amount
of medical information with their personal physicians. In most
cases these physicians store the information about their patients
as digital records by using the electronic healthcare record

(EHR). These types of records are very inefficient mainly for
the clients or the patients. This is because the information that
is stored in this means is not available to the patient themselves
or other physicians .Access can only be availed to other
physicians only if the hospital is in an integrated system
something that most of them are not. More sadly, the main
physicians most of that times experiences delays accessing the
patient data needed to treat a patient.
This is very worrying, especially in emergency situations. For
example assume that an individual collapses while in a work
vacation in another town and is rushed to the nearest hospital.
To be able to identify quickly the problem, the doctors may
need prior medical records that are not available in this kind of
a system. This is why having a centralized information database
is very important. A centralized system removes all the bars that
are there in the access of effective medical care. It enables a
patient to have access to their medical record and gives them
the freedom to visit any physician and still have quick access to
the data (Lima, John &Liebler 2008). A centralized system
helps to make access to health care flexible for the patients.
With such a system health care provision is highly improved
since any physician can treat an individual with the background
of the prior medical records.
The centralized system also helps to add data to the clients
because when all the medical records can be accessed from one

point, it makes it easy to make strategies of improving
healthcare. Organizations that are concerned with formulating
policies on how to improve healthcare can be able to have
access of all the data from the same point and thus easily
identify the major areas where more intervention is needed.
Give an overview of all the value this project will bring to the
business.
This system does not only add value to clients and the
consumers, but it also adds a lot of value to the healthcare
sector itself. With this system, the business bears a ton of
benefits along with it. First there is an increase the security of
information. One of the main objectives of health care and
health care professionals is to uphold the confidentiality of the
information of all their clients. With the small electronic record
systems, the information is subject to a lot of cyber security
issues mainly because they lack the complexity needed to
prevent the hacking and many other cyber-crimes. With the
centralized system, the level of security for the patient
information is taken to a whole other level. For example, for
one to have access to information according to this project one
has to have an insurance card that is used to access to medical
records. The card itself has locks such as pins to ensure that
only the owner can use it. With this, access to personal medical
information is based on personal terms.
The centralized system of medical record keeping also helps

the business to be more effective and efficient (State of
California 2015). First it helps to ensure that any physician can
have access to past medical records of a patient when treating
the patient and this makes the administration of medical care
easy and also very effective. This is because they can be able
to make decisions on how to treat a patient with the background
of the past diagnosis and past health conditions. With the prior
medical records, the doctors can decide what drugs to
administer and what not to for example if the patient shows
allergic reactions in the past. Second this system makes health
care effective since the system ensures uniformity of records
making it standard and easy to interpret.
This is a very crucial and a highly needed intervention in health
care right now and this forms the basis as to why the project
should be funded. This project is very holistic and helps to
provide a highly needed solution to some of the main problems
facing health record management today. The system suggested
by the project will not only solve the problem of the
inflexibility of access to healthcare, but it will also help to
address the issue of security in the health records of the clients.
This system will also help to standardize healthcare practice,
ease the management of health care information and also ensure
simple analysis of health care trends. This makes health care
services more efficient, and it is for this reason that it needs to
be funded.

The system proposed in this project helps to increase business,
in this case, referring to healthcare in the sense that the main
objective for healthcare is to reduce the rate of disease and to
improve health status. By making healthcare more accessible
and by making the analysis of health records easy such that
organizations involved in the health information analysis have
one point of reference helping them to identify the areas of
priority.
The cost may not be reduced at first due to the costs that come
with the management of the large data sets but with time ways
of saving on the cost will result in a reduction in cost
Bibliography
About the Medicare-Medicaid Coordination Office. (2015, 03
17). Retrieved 01 13, 2016, from CMS:
https://www.cms.gov/Medicare-Medicaid-
Coordination/Medicare-and-Medicaid-Coordination/Medicare-
Medicaid-Coordination-Office/
Affordable Care Act Update: Implementing Medicare Cost
Savings. (2010, 10). Retrieved 14 01, 2015, from CMS:
https://www.cms.gov/apps/docs/aca-update-implementing-
medicare-costs-savings.pdf
ASPA. (2014, 11 18). HHS. Retrieved 01 14, 2015, from
Healthcare Facts And Features:

http://www.hhs.gov/healthcare/facts-and-features/key-features-
of-aca/index.html
Charvat, J. (2002, 11). Techrepublic. Retrieved 01 12, 2016,
from Project communications: A plan for getting your message
across: http://www.techrepublic.com/article/project-
communications-a-plan-for-getting-your-message-across/
Nayab, N. &. (2011, 05). Developing a Project Management
Staffing Plan. Retrieved 01 12, 2016, from brighthubpm:
http://www.brighthubpm.com/project-planning/88606-
developing-a-project-management-staffing-plan/
State Of California. (2015). California Department of Health
Care Services. Retrieved 01 09, 2015, from What Is Hipaa:
http://www.dhcs.ca.gov/formsandpubs/laws/hipaa/Pages/1.00Wh
atisHIPAA.aspx
The National Federation Of Independent Business V Sebellius,
Secretary Of Health And Human Services. (2012, 06 28).
Retrieved 01 14, 2015, from Supreme Court :
http://www.supremecourt.gov/opinions/11pdf/11-393c3a2.pdf
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Chapter 21
Toxicity Testing
Toxicity Testing
• There are two purposes of toxicity testing.
– There is a quantitative effort to elucidate a
dose–effect relationship
– There is a qualitative determination of the
toxicity of the agent relative to other known
chemicals.
Toxicology testing, cont.
• Both purposes are accomplished using laboratory

animals and in vitro methods.
– There are ethical concerns associated with whole
animal studies as the intent of toxicity testing is to
produce harm to the animal and then extrapolate
the results to humans.
– Extrapolation magnifies error, so standards have
been developed using uncertainty factors and
modifying factors.
– Application of the results from animal testing can
improve safety and help prevent injury.
Toxicity Testing
• The toxic effects of chemicals are determined
by:
– The nature of the chemical hazard
– The dose or quantity to which the individual is
exposed

– The pathway(s) of exposure
– The pattern of the exposure
– The duration of the exposure
• In toxicity testing the importance of the dose
or concentration and the hazardous nature of
the chemical may vary considerably
depending on the route of exposure.
• A chemical may be poorly absorbed through
the skin but well absorbed orally.
– Because of such route-specific differences in
absorption, toxicants are often ranked for hazard

in accordance with the route of exposure.
– For example, a chemical may be relatively
nontoxic by one route of exposure and highly toxic
via another route of exposure.
– Accordingly, toxicity testing should be conducted
using the most likely routes for human exposure.
Toxicity Information
• Toxicity information is obtained primarily by
– Use of laboratory animals (in vivo studies)
– Surrogate animal models such as cell culture
systems [SARs] (in vitro studies)
– Human data obtained from intentional or
accidental exposures to chemical agents
– Nonbiological models (computers, structure–
activity relationships [SARs])

Toxicity Information, cont.
• A great deal of information is available on the
toxicity of chemicals from whole animal
studies, in vitro studies, and epidemiological
studies. There are advantages and
disadvantages for each of these types of
studies.
Exposure Durations
• One of the most important considerations in
toxicology is the duration and frequency of exposure
to a chemical. This is also an important consideration
in developing toxicity tests. There are basically four
types of exposure durations:
– Acute
– Subacute

– Subchronic
– Chronic exposure
Exposure Duration: Acute
• Generally refers to an exposure lasting less than
24 hours, and in most cases it is a single or
“continuous” exposure over a period of time
within a 24-hour period.
• For example, a single oral exposure to 10 ml of an
organophosphate pesticide or the inhalation of
toluene in the air that we are breathing at 150
ppm over a period of 3 hours would constitute
examples of acute exposures.
Exposure Duration: Subacute
• Generally refers to repeated exposure to a

chemical for a period of 1 month or less.
Exposure Duration: Subchronic
• Generally refers to repeated exposure for 1–3
months.
Exposure Duration: Chronic
• Generally refers to repeated exposure for
more than 3 months.
Toxicity Studies
• Toxicity studies are conducted for chemicals
that have the potential for public exposure;
however, the extent of the toxicity testing and
therefore the complexity of the study depend
on several considerations:

– The specific type of chemical hazard
– How it is to be used
– The projected levels of human exposure
– The extent of its release into the environment
Toxicity Studies, cont.
• As you might anticipate, any study involving
chemicals such as food additives, agricultural
chemicals, pharmaceuticals, and veterinary
drugs would undergo more extensive toxicity
testing than chemicals that have limited use,
perhaps in a specific industrial or research
application.
Toxicity Studies, cont.

• Toxicity testing using laboratory animals is
often the only initial means by which human
toxicity can be predicted and is often the only
acceptable means for safety testing that
satisfies certain regulatory requirements.
Toxicity Testing
• To be meaningful, any test for toxicity must
contain the following three stipulations:
– An appropriate biological model
– An end-point that can be qualitatively and
quantitatively assessed
– A well-developed test protocol
Meaningful Toxicity Testing
• An appropriate biological model

– The model represents the system that is used for
evaluation.
– This may involve the use of whole animals (in vivo
testing) or an appropriate in vitro test system.
– When in vitro models are used, one should be
selected that best represents what is believed to
be occurring in the whole animal.
• An end-point that can be qualitatively and
quantitatively assessed
• The measurement end-point is an appropriate
parameter that can be used to predict toxicity.
• Toxicological end-points are the biological
responses to chemical insult.
• They represent a measure of interaction

between toxicant and living system.
• The term toxicodynamics is sometimes used
to refer to this dynamic interaction.
• This end-point can be as crude a measure as
lethality or as subtle as a nonclinically
detectable change in cellular DNA.
• A well-developed test protocol
– The test protocol is the schedule that defines the
conditions related to dosing and time, and
provides all experimental details, including
statistical methodology.

Toxicity Studies
• Toxicity studies using laboratory animals thus
provide a basis for:
– Understanding how a chemical may potentially
produce an adverse response in humans
– Demonstrating a range of exposure levels and
gradation of toxicity from no observable effects to
severe toxicity
– Justification for public health risk assessments
Toxicity Studies
• It must be recognized, however, that although
the intent of such studies is to provide
information that would be predictive of
effects in humans, responses vary between
animal species because of anatomical,
physiological, and biochemical differences,

and this limits to some extent our confidence
as to human applicability.
Table 21-3 Extrapolation of Animal
Results to Humans
Table 21-4 Equivalent Dose Levels
in Several Species
Acute Local Toxicity
• Irritation and corrosion tests are examples of
local tissue responses.
– The chemical being tested is applied to the skin of
the test animal and over a period of time,
generally hours to a few days, the skin is examined
for signs of inflammation.

– When these types of tests are performed on the
eyes, it is referred to as the Draize test.
Irritation and corrosion tests, cont.
– The ocular toxicity of irritants is determined by the
brief application of the substance to the eyes of
several test animals, which are usually rabbits.
– Examination of the eyes is conducted over a
period of 3 days to assess for any injuries that may
have been produced to the conjunctiva, cornea, or
iris.
– Substances have been demonstrated to produce a
range of effects from no observable reaction or
simple reversible irritation to severe irritation and
corrosion.
Acute Local Toxicity, cont.

• Some chemicals have the potential to produce a
direct irritating/inflammatory skin response while
others may need to first be processed by
immunological sensitization.
– In the latter process, skin injury is not the direct
effect of the chemical on the skin, but rather an
indirect response from the release of mediators of
inflammation upon re-exposure in the sensitized
individual.
– Rabbits are generally used for these types of
studies.
• To determine whether the chemical produces
a primary irritant response (contact
dermatitis), the substance is applied to the
skin and any changes are observed over the
course of several days.

• To assess for an immunological response,
guinea pigs are first treated with the chemical
by its topical application to the skin for several
hours (sensitization phase).
– There should be no inflammatory changes to the
skin over the course of a week or two.
– The substance is then reapplied to the skin (skin
challenge) and observations are made over a
period of one to several days.
Acute Systemic Toxicity
• Toxicological prechronic tests typically use
rodents of both sexes, over a period of either
24 hours (acute), 14 days (the subacute or 2-
week study), or 90 days (the subchronic or 13-
week study).

LD50
• A simple end-point measure used for many years is
the LD50.
• This is a dose (generally orally administered) that is
statistically derived from laboratory animals and
represents the dose at which 50% of the test animals
would be expected to die.
• In the late 1920s the LD50 test was developed as a
measure of the toxicological potency of chemicals
intended for human use such as insulin and digitalis.
LD50
• The use of the test was expanded to one that
was generally recognized as an acceptable in
vivo animal surrogate to rank chemical toxicity
and became accepted for regulatory purposes
as an important source of safety information

for new chemicals, including drugs, household
products, pesticides, industrial chemicals,
cosmetics, and food additives.
LD50 Curve
Efficacy, Toxicity, and Lethality
• For many chemicals that we intentionally use,
some benefit is derived from their use.
– For example, a prescribed medication is
anticipated to produce a beneficial effect if
properly taken.
– The level of benefit (efficacy) can also be
quantitatively measured; thus an ED50 would
represent the lowest dose that is beneficial
(efficacious) in 50% of the test population.

Efficacy, Toxicity, and Lethality,
cont.
• It should be apparent that for a chemical
intended to produce some benefit to the body
at a certain dose, the likelihood of some
toxicity may also result from the same
chemical at some dose beyond therapeutic.
– Any dose that results in a toxic end-point
(nonlethal) can be abbreviated TD.
– Thus, a TD50 would represent the dose of a
chemical toxic to 50% of the population.
Efficacy, Toxicity, and Lethality,
cont.
• For chemicals that produce a beneficial effect,
e.g., a drug, a comparison of the doses that
produce efficacy and those that produce
toxicity can yield important information

regarding its safety.
Case in Point
• Let us consider the acute toxicity of a hypothetical
chemical “X” (Table 21-7).
• The empirically derived data table does not precisely
reveal what the LD50 is; it is only known that it rests
somewhere between 20 and 30 mg/kg and can be
better approximated by drawing a horizontal line from
the 50% lethality point on the curve and then a
perpendicular line to the dose intercept
• Because the dose–response curve is not a straight line,
caution must be used in making an LD50 estimate.
Table 21-7 Acute Lethality from Oral Doses
of Chemical “X” in Laboratory Rats

Figure 21-5 Acute lethality from oral doses
of chemical “X” in laboratory rats
Case in Point, cont.
• There are a number of methodologies to more
precisely calculate the LD50.
• In a population that is normally distributed,
the mean ± 1 standard deviation represents
68.3% of the population, the mean ± 2
standard deviations represents 95.5% of the
population, and the mean ± 3 standard
deviations represents 99.7% of the
population.
• Because dose–response characteristics are
usually normally distributed, the percent of

response can be converted to units of
deviation from the mean, or what is referred
to as normal equivalent deviations.
• The probit (from probability unit) is, by
convention, the normal equivalent deviation +
5.
• A 50% response is a probit of 5, a + 1 deviation
becomes a probit of 6, and a – 1 deviation is a
probit of 4 (Table 21-8).
• A probit transform of the data would produce
a graph with a straight line (Figure 21-6). Dose
is expressed in both mg/kg and log of dose.
Figure 21-6 Acute lethality from oral doses of
chemical “X” in laboratory rats: probit graph.

Table 21-8 Probit Referenced to % Response and
Normal Equivalent Deviations (NED)
Margin of Safety
• Perhaps a better designation to describe the
safety of a drug is that of the margin of safety
(MOS), which overcomes the problem of any
significant differences in the response slopes
between toxicity and efficacy curves.
– The MOS represents the ratio of lethality at a very
low level (e.g., 1%) compared with efficacy at the
99% level (MOS= LD1/ED99).
– The higher the value, the safer the drug.
Human Studies

• Toxicity information from human studies may
come from a number of sources:
– Case reports from individuals that have been
accidentally or intentionally poisoned
– Reported adverse reactions to drugs
– Clinical studies from various sized groups of
individuals that have been intentionally exposed
to an investigational chemical, such as a new
pharmaceutical
Human Studies, cont.
• Epidemiological studies that attempt to determine
whether a causal relationship exists in a study
population that has been exposed to a substance that
may produce adverse health effects when compared
with an unexposed population that has been matched
for such factors as age, gender, race, and economic
status.

• An example of such a study might be to determine
whether a greater incidence of a specific disease (e.g.,
asthma) in a community is associated with the
discharge of pollutants from a specific geographical
area.
Human Studies
• Although epidemiological studies offer
obvious advantages over laboratory studies,
there are nonetheless a number of
disadvantages:
– The tests are often expensive to conduct.
– Good quantification of exposures is frequently
difficult.
– Large numbers of individuals are acquired for
meaningful statistical evaluation.

Human Studies
– Exposure quantification in humans is frequently
difficult because of simultaneous exposures to
multiple chemical, physical, and biological agents.
– Epidemiological studies generally require long
periods of time before information is made
available through the appropriate published
resources.
Alternatives to Animal Testing
• Toxicologists as well as other scientists who
use animals for research and testing purposes
have been encouraged to explore the “3R’s” of
animal alternatives:
– Replace the animal with another appropriate test.
– Reduce the total number of animals used.
– Refine the study to reduce the distress of

laboratory animals.
Alternatives to Animal Testing:
in vitro limitations
• The replacement of laboratory animals with
an appropriate in vitro test is often not a
viable option.
– Accepting an in vitro methodology as a suitable
surrogate for an in vivo test requires its validation.
– The in vitro methodology must be implementable
by multiple laboratories, and consistent results
must be produced, that is, the new methodology
must be validated.
Alternatives to Animal Testing:
in vitro limitations
– Validation may be defined as a process by which

the credibility of a new test is established for a
specific purpose and its reliability and
reproducibility have been verified by independent
sources.
– Although a large number of in vitro tests are
available, most of them have not been validated
and are unacceptable for regulatory purposes.
In Vitro Methodologies
• Mutagenicity and
Chromosome Damage
• Tumor Promotion
• Cytotoxicity
• Eye Irritation
• Cardiac Muscle
Toxicity

• Nephrotoxicity
• Hepatotoxicity
• Endocrine Toxicity
• Respiratory Toxicity
• Reproductive Toxicity
• Ecological Toxicity
Tests
Websites
• Chemical Toxicity Database:
http://wwwdb.mhlw.go.jp/ginc/html/db1.html
• National Toxicology Program: http://ntp-
server.niehs.nih.gov/
• The Centers for Disease Control:
http://www.cdc.gov/

• The Department of Health and Human Services:
http://www.hhs.gov/
• The Environmental Protection Agency:
http://epa.gov/
http://wwwdb.mhlw.go.jp/ginc/html/db1.html
http://ntp-server.niehs.nih.gov/
http://www.cdc.gov/
http://www.hhs.gov/
http://epa.gov/
Websites
• The Food and Drug Administration:
http://www.fda.gov/
• The National Toxicology Program
http://ntp.niehs.nih.gov/
• U.S. Department of Labor Occupational Safety &
Health Administration: http://osha.gov/

• U.S. FDA Center for Food Safety and Applied
Nutrition: http://www.cfsan.fda.gov/
http://www.fda.gov/
http://ntp.niehs.nih.gov/
http://osha.gov/
http://www.cfsan.fda.gov/

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