The Importance Of Fast Track Designation

The Importance Of Fast Track Designation
Accelerated Pathways (APs) for the development of new drugs in the U.S., Europe, and Japan are
intended to bring needed and important new treatments to patients more quickly which have
multiplied in recent years and have proven to present opportunities and benefits for patients and
developers (Parexel, 2016). Accelerated Approval (AA) was created by FDA regulation in 1992, in
response to the emergence of the AIDS epidemic (Health Affairs, 2017). It was codified by the FDA
Safety and Innovation Act (FDASIA) in 2012 (Health Affairs, 2017). Using AA, the FDA may grant
approval for a new drug that offers a significant benefit compared to available therapies for serious
medical conditions where there is unmet medical need, based on preliminary ... Show more content
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In general, the preliminary clinical evidence should show a clear advantage over available therapy
(FDA, 2015). Accelerated Approval can sometimes take many years to learn whether a drug actually
provides a real effect on how a patient survives, feels, or functions when studying a new drug (FDA,
2015). A positive therapeutic effect that is clinically meaningful in the context of a given disease is
known as clinical benefit (FDA, 2015). Mindful of the fact that it may take an extended period of
time to measure a drug's intended clinical benefit, in 1992 FDA instituted the Accelerated Approval
regulations (FDA, 2015). These regulations allowed drugs for serious conditions that filled an unmet
medical need to be approved based on a surrogate endpoint (FDA, 2015). Using a surrogate
endpoint enabled the FDA to approve these drugs faster (FDA, 2015). Priority Review will direct
overall attention and resources to the evaluation of applications for drugs that, if approved, would be
significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of
serious conditions when compared to standard applications (FDA, 2015). Prior to approval, each
drug marketed in the United States must go
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Freedom And Freedom : The Importance Of Clinical Freedom
Clinical freedom is the right of medical practitioners to decide and do whatever in their opinion was
best for their patients. It had been common practice that medical practitioners subject patients to
treatment procedures without any evidence of their efficacy, which not only will increase
expenditures, but also may put patients to potential harm. Hampton considered clinical freedom as a
myth and 'a cloak of ignorance', and believed that medical practitioners should base their clinical
practice on evidence from randomized controlled trials to guide medical decision making and set
aside dogma and biases (1). Using an example from the issue of active management of myocardial
infarction, the author highlighted the importance of managing resources effectively on clinical and
economic considerations, and suggested that interventions should not only be assessed for their
efficacy in increasing likelihood of their desired effect, but also assessed with comparative trials
against other alternative treatments. (1). In his conclusion, author felt that the end of clinical
freedom is not to be regretted, for its end would allow treatment to be applied only after a properly
conducted clinical trial and approved on a large scale after considering available resources and the
efficacy of treatment.
This paper raises interesting questions in economics and resource management healthcare
Furthermore, the procedures would also have to be compared with other alternatives in terms of
cost.

Clinical Trial Endpoints Case
Topic: You are designing a clinical trial for a drug company. How would you identify study
endpoints that are meaningful to patients?
Statement of Problem:
Treatment effectiveness has been defined as a clinically significant benefit to the patient, with the
objective of the patient living for longer or better, or both, than if they did not receive the treatment
(Wilson et.al., 2015). This measure of efficacy might be shown by symptomatic improvement, or
improvement in established disease progression endpoints (Wilson et.al., 2015). Since clinical trial
endpoints have profound effects on late phase clinical trial design, result interpretation, drug
development, and regulatory approval of therapeutics, the characteristics of the disease and ... Show
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Finally, clinical trial endpoints and the standards to which they are held significantly impact the
regulatory and approval process for new drug applications.
References:
1. Casarett, D., Karlawish, J., Sankar, P., Hirschman, K., & Asch, D. A. (2001). Designing Pain
Research from the Patient's Perspective: What Trial End Points Are Important to Patients with
Chronic Pain? Pain Medicine,2(4), 309–316. doi:10.1046/j.1526–4637.2001.01041.x
2. Herzog, T. J., Armstrong, D. K., Brady, M. F., Coleman, R. L., Einstein, M. H., Monk, B. J., . . .
Alvarez, R. D. (2014). Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology
white paper. Gynecologic Oncology,132(1), 8–17. doi: 10.1016/j.ygyno.2013.11.008
3. Minion, L. E., Coleman, R. L., Alvarez, R. D., & Herzog, T. J. (2016). Endpoints in clinical trials:
What do patients consider important? A survey of the Ovarian Cancer National Alliance.
Gynecologic Oncology,140(2), 193–198. doi: 10.1016/j.ygyno.2015.11.030
4. Wilson, M. K., Karakasis, K., & Oza, A. M. (2015). Outcomes and endpoints in trials of cancer
treatment: the past, present, and future. The Lancet Oncology,16(1).

History of Acquired Immune Deficiency Syndrome Essay
History of Acquired Immune Deficiency Syndrome
Acquired Immune Deficiency Syndrome (AIDS), specific group of diseases or conditions that result
from suppression of the immune system, related to infection with the human immunodeficiency
virus (HIV). A person infected with HIV gradually loses immune function along with certain
immune cells called CD4 T–lymphocytes or CD4 T–cells, causing the infected person to become
vulnerable to pneumonia, fungus infections, and other common ailments. With the loss of immune
function, a clinical syndrome (a group of various illnesses that together characterize a disease)
develops over time and eventually results in death due to opportunistic infections (infections by
organisms that do not normally cause ... Show more content on Helpwriting.net ...
About 430,000 of these deaths occurred in the United States. II CLINICAL PROGRESSION OF
AIDS
The progression from the point of HIV infection to the clinical diseases that define AIDS may take
six to ten years or more. This progression can be monitored using surrogate markers (laboratory data
that correspond to the various stages of disease progression) or clinical endpoints (illnesses
associated with more advanced disease). Surrogate markers for the various stages of HIV infection
include the declining number of CD4 T–cells, the major type of white blood cell lost because of
HIV infection. In general, the lower the infected person's CD4 T–cell count, the weaker the person's
immune system and the more advanced the disease state. In 1996 it became evident that the actual
amount of HIV in a person's blood–the so–called viral burden–could be used to predict the
progression to AIDS, regardless of a person's CD4 T–cell count. With advancing technology, viral
burden determinations are quickly becoming a standard means of patient testing.
An infected person's immune response to the virus–that is, the person's ability to produce antibodies
against HIV–can also be used to determine the progression of AIDS; however, this surrogate marker
is less precise during more advanced stages of AIDS because of the overall loss of immune function.
Within one to three weeks after infection with HIV, most people experience nonspecific

Technological Advancements Through The Years
Innovation Through The Years Where would society be without progress? Think about life without
out the simplest necessities of the 21st century. No Wi–Fi. No innovative cancer leading research
labs and technology. No 3D technology or printers. Innovations and innovative thinking are two
major driving impetuses of progress. Innovation can best be described as "something new that
creates new opportunities for growth and development"("A World Transformed" 1). There are many
opportunities for progress and development now days and anyone can take advantage of them. The
cultivation and accumulation of innovations over the years has created a very sculpted,
advantageous society. One of the many technological advancements that has help change society
overtime is Magnetic Resonance Imaging (MRI), and it continues to be enhanced to lead to more
cutting edge health care. The "father of the MRI" is what Dr. Raymond Damadian is best known as,
although there has been major controversy over who exactly made this medical discovery.
Damadian's medical breakthrough happened in the years 1970–1973 when experimenting with
nuclear magnetic resonance on bacteria and realized that his findings and techniques could be
applied to other things besides bacteria. He applied his knowledge in what he learned from his
experimenting with salt in bacteria to trying to diagnose cancer and other diseases in the human
body. His overall work up to his final product of the MRI took several years of research

Safety Of The Hpv Vaccine Essay
Safety of the HPV Vaccine There have been concerns about the safety of the HPV vaccines. In
Basu's (2013) article they reviewed the evidence from the phase III trials and national programs for
the HPV vaccine. After reviewing the data though the article showed that all the randomized control
trials reported both their serious and non–serious adverse events that took place during the phase III
trials. "There were 20,000 participants in the trial" (p.4). Pain at the injection site, headache, and
fatigue were the most frequently reported issues. The serious adverse effects were very rare so the
vaccine was considered safe. When reviewing the safety data from the national programs in
Australia there were millions of doses given out and the most adverse side effects there were
anaphylactic and allergic reactions, and these were not seen as any more dangerous than it is for
other vaccines. "In the US about 40 million doses were given out and among the reports that were
received by the Vaccine Adverse Event Reporting System which totaled 20,096 only 8% of these
reports were actually were considered serious"(p.5). All the reports were reviewed and could not
find any adverse events that occurred that could be ascribed to the vaccine. In the UK they reviewed
the vaccine two years after it came out and concluded it to be safe. Reviewing the data from all three
counties in the national programs showed that none of the deaths that occurred could be linked to
the vaccine. So both the

Review
Order Code RS22814 February 21, 2008 FDA Fast Track and Priority Review Programs Susan
Thaul Specialist in Drug Safety and Effectiveness Domestic Social Policy Division Summary By
statutory requirements and by regulation, guidance, and practice, the Food and Drug Administration
(FDA) works with several overlapping yet distinct programs to get to market quickly new drug and
biological products that address unmet needs. FDA most frequently uses three mechanisms for that
purpose: Accelerated Approval, Fast Track, and Priority Review. The first two affect the
development process before a sponsor submits a marketing application. Accelerated Approval
allows surrogate endpoints in trials to demonstrate effectiveness and is ... Show more content on
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105–115) directed the Secretary to create a mechanism whereby FDA could designate as "Fast
Track" certain products that met two criteria. First, the product must concern a serious or life–
threatening condition; second, it has to have the potential to address an unmet medical need. Once
FDA grants a Fast Track designation, it encourages the manufacturer to meet with the agency to
discuss development plans and strategies before the formal submission of an NDA/BLA. The early
interaction can help clarify elements of clinical study design and presentation whose absence at
NDA/BLA submission could delay approval decisions. However, FDA makes similar interactions
available to any sponsor who seeks FDA consultation throughout the stages of drug development. A
unique option within Fast Track is the opportunity to submit sections of an NDA/BLA to FDA as
they are ready, rather than the standard requirement to submit a complete application at one time.4 2
Other options fit very limited situations and support shorter times from idea to approved public use.
The Animal Efficacy Rule (21 CFR 314 Subpart I and 21 CFR 601 Subpart H) allows submission of
data from animal studies of effectiveness as evidence to support applications of certain new products
"when adequate and well–controlled clinical studies in humans cannot be ethically conducted and
field efficacy studies are not feasible." The Project

Rivaroxaban Essay
Rivaroxaban is a factor Xa inhibitor that may be useful as a treatment for deep–vein thrombosis
without the need monitoring that vitamin K antagonists like warfarin require. Standard treatment for
acute deep–vein thrombosis consists of initial parenteral heparin with co–administration and
followed use of vitamin K antagonists. However, vitamin K antagonists need to be monitored due to
a high risk of bleeding. EINSTEIN Study GENERAL STUDY OVERVIEW Oral Rivaroxaban for
Symptomatic Venous Thromboembolism Bayer Schering Pharma and Ortho–McNeil Rivaroxavan is
not effective as a treatment for acute deep–vein thrombosis or acute pulmonary embolism The Acute
DVT Study is a randomized, open–label study, which is appropriate because the study is comparing
... Show more content on Helpwriting.net ...
The causes of premature discontinuation are adverse events, consent withdrawal, and loss to follow–
up. Patient demographics are reported as well, and the authors provide a useful table with basic
patient information including age, weight, gender, and renal function. There are some very
miniscule differences in groups for both studies, but these differences should not affect the results
because of randomization. The trial results are reported in percentages of event occurrence in a
population. While these are useful in understanding the frequency of harmful effects or successful
treatment, a surrogate measurement and use of INR measurements may provide a better idea of the
extent of safety or efficacy. In the Acute DVT Study, the primary efficacy endpoint occurred in 2.1%
of rivaroxaban patients and in 3.0% of standard therapy patients (Hazard ratio 0.68; 95% CI 0.44 to
1.04; P<0.001 for non–inferiority with a one–sided test, and P = 0.08 for superiority with a two–
sided test). The principal safety endpoint of clinically significant bleeding occurred in 8.1% of
rivaroxaban patients and in 8.1% of standard therapy patients (hazard ratio with rivaroxaban 0.97;
95% CI 0.76 to 1.22; P =

Deep Packet Inspection Paper
Jason Marshall
ENG105
Deep Packet Inspection
This paper will weigh the implications of Deep Packet Inspection and its effects on our network
security and personal privacy. The Internet and network security are among the most important
aspects of how people communicate with each other in the world today. With each leap toward the
technological horizon, more threats and more solutions are implemented, and the systems on both
sides are ever evolving. Deep Packet Inspection (DPI) is a type of security measure that goes
beyond making sure the data packets we send get to their destination, and that they are the correct
data packets. DPI dives deeper into the packet, and looks at the data portion, or the information
contained within the packet. Along with added security, another factor comes into play: Privacy.
Does the security of our data warrant the invasion of our privacy, whether we know about it or not?
... Show more content on Helpwriting.net ...
Firewalls are software or hardware appliances that allow, prevent, detect, and warn about data
packets being sent to and from the specified network(s). Generally, these are set up as rule–based
devices, where administration configures these rules to allow or deny certain types of data,
depending on source and destination IP address and port numbers. Dr. Porter, a security architect
with Avaya's Global Managed Services division, explains typical firewall properties. The first
firewalls were basically just gateways between two networks with IP forwarding disabled. Most
contemporary firewalls share a common set of characteristics, as laid out by Dr.

Our Comprehensive Synthesis Of Available Evidence Showed A...
Our comprehensive synthesis of available evidence showed a strong association between the LISA
and the risk of late/very late ST and MI during the post imaging follow up. The low incidence of ST
events over 18,145 person–months follow up (≈1.4% ST per person–year) in LISA group explains
the limited power of previous studies evaluating this association. Our results are consistent with a
prior meta–analysis of five studies which found LISA to be associated with increased risk of late ST
(OR = 6.51; 95% CI 1.34–34.91)(13). We extended these findings by including 11 additional studies
and longer follow up of previous studies published subsequently. Also, we accounted for variable
follow up period of included studies by using person–months as offset rather than the number of
patients in each group. Moreover, as recommended in literature (17–18), we used multiple statistical
methods as part of our sensitivity analysis to assess the robustness of our findings. Our finding stood
the test of these sensitivity analysis confirming a strong association between LISA ( and LAISA)
and late/very late ST. Although we found a significant association between LISA and clinical events
(ST and MI), our results do not establish a cause and effect relationship. The two cohorts, LISA and
control, were unbalanced on one or more characteristics in all included studies. For instance, LISA
group had longer stents and more commonly associated with acute coronary syndrome as the
indication for PCI in

Transplant ( NODAT ) : Risk Factors For Overcome...
Abstract New onset diabetes after transplant (NODAT) is an important complication after
transplantation that increases risk for poor patient and graft outcomes. Recent studies in children
identified older age, extremes of body mass index (BMI), and corticosteroid use at discharge as risk
factors for NODAT. However, these studies were conducted in a national sample which underrated
certain patient groups like deceased donor transplants and African American recipients. The purpose
of this study was to determine the association between acute rejection (a surrogate for increased
corticosteroid exposure) and NODAT in a pediatric kidney transplant program. A retrospective chart
review was performed on a cohort of 121 consecutive pediatric kidney ... Show more content on
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The main risk factors include age ≥50 years old, male gender, family history of diabetes, and high
systolic pulmonary artery pressure (PAP) >50mmHg.1,2 A review of data from the United States
Renal Data System for primary renal transplant recipients ≤21 years old transplanted between 1995
and 2004 found the following risk factors for NODAT: African American children, BMI ≥ 30,
increased age of child at time of transplant (≥13 years old), discharged on tacrolimus, and
cytomegalovirus donor positive/recipient negative status.2 Cytomegalovirus (CMV) is herpes virus
that is present in over sixty percent of adults that generally only causes non–specific fever and flu–
like symptoms in immunocompetent hosts. In immunosuppressed transplant patients however, the
virus can develop into a systemic infection involving several organ systems and increase the risk for
transplant rejection.3 Other studies in children also identified corticosteroid use at discharge as a
risk factors for NODAT.4 There have been no studies exploring the risk factors for NODAT in a
population similar to that at Children's of Alabama, which is distinct due to a large number of
deceased donor transplants and African–American recipients with higher immunologic risk. The
purpose of this study was to determine the association between acute rejection (a surrogate for
increased corticosteroid exposure) and NODAT in this kidney transplant program. Methods Before
initiation of this research, a literature

My Career As A Sex Therapist Essay
The occupation that I have chosen for this assignment is a Sex Therapist. I am a senior at the
University of Wisconsin– La Crosse and my career goal is to become a Sex Therapist, for the future.
How I got interested in this occupation is that I knew that I wanted to help people in some way, but I
didn't exactly know how I was going go about that. I grew up in a family environment that talked
about sex very openly. Which today, has made me feel comfortable taking about sex and I have
found that sexual topics are interesting to learn about. I changed my major to Psychology, which
will help me prepare for my career, because I plan to work in a clinical setting that deals with
diagnosing people based on their behaviors. Studying psychology is all about the mind's functions
and how it affects behavior. In the following paragraphs I will explain in–depth of background
knowledge and the educational requirements for pursuing a career as a Sex Therapist. Also,
providing information about the salary, competitiveness, type of job locations, and expectations. For
this assignment I interviewed Jill O'Brien, who is a Physical Therapist that works at Gundersen and
runs her own clinic that specializes in Pelvic Health. This is not the exact career that I want, but her
specialized interest is something similar to the type pf clients I could work with in the future. I could
not job shadow a Sex Therapist, due to confidentiality reasons. These are the topics I will be
describing in more depth

The Care Of Heart Failure Patients Essay
Does the Use of Telemonitoring in the Care of Heart Failure Patients Reduce Hospitalization?
The heart is a vital organ that the body needs in order to survive and according to the Center for
Disease Control (CDC) 5.7 million people in the United States suffer from heart failure (HF) and
about half of heart failure patients die within five years of diagnosis, (CDC, n.d.). Heart failure is the
inability of the heart to pump blood sufficiently in order to meet the body's need. Heart failure is the
main reason for inpatient hospitalization and readmission in adults over 65 years old (Smith, 2013).
Advances in technology continue to change the practice of nursing and healthcare. Telemonitoring is
one major advance in technology that is changing the role and practice of nursing today.
Telemonitoring involves healthcare workers remotely monitoring patient's vital signs daily with the
goal of early detection of deteriorating conditions. This systematic review will present available data
regarding telemonitoring in heart failure patients and hospitalization.
Research Question Does the Use of Telemonitoring In the Care of Heart Failure Patients Reduce
Hospitalization?
Systematically Reviewed Literature
Telemonitoring Reduces Hospitalizations
Pedone et al. (2015) conducted a randomized trial study that evaluated the effect of telemonitoring
and hospital admissions of elderly patients with heart failure. The study involved a final sample size
of 90 participants: 43 from

The Politics and Economics of FDA Drug Approval Essay
The Politics and Economics of FDA Drug Approval
The United Sates Food and Drug Administration has been protecting American consumers for
around 70 years. The FDA assures the safety drugs, medical devices, chemicals, cosmetics, foods
and additives by evaluating products for approval. Controversy has recently been surrounding the
FDA's drug approval process, due to a general trend to get pharmaceuticals on the market more
quickly. The FDA has been under pressure from congress and the public to speed approval, but
pharmaceutical companies, who benefit more than anyone form accelerated drug approval, have also
been applying pressure to the FDA through congress. The speeding of the approval process helps
patients with incurable illnesses ... Show more content on Helpwriting.net ...
The Radiation Control for Health and Safety Act guarantees consumers protection from excess
radiation in certain devices. Lastly, The Public Health Service Act expanded the FDA's authority to
cover serums and vaccines and also justified the inspections of restaurants (Food and Drug
Administration [Britannica]). The FDA is adjusting to a switch in leader ship since Jane Heney,
previously the FDA's deputy commissioner of operations, was nominated in June 1998. Heney, the
first woman to head the FDA, has a packed resume that includes a vice presidency of the University
of New Mexico and a specialization in cancer research. Her strategy for the future of the FDA
includes the enforcement of new federal laws to modernize the FDA and addressing concerns about
drug safety and approval speed, as well as controlling food contamination (Davis 5D). The FDA
requires pharmaceutical companies to conduct years of research on their drugs before they begin the
actual process approval. Drug companies submit test results to the FDA to be reviewed by their
scientists; the FDA actually does no preliminary research on the drugs. In order to be approved, the
companies must prove to the FDA that each drug is safe and effective and that the benefits of the
drug must outweigh its side effects. The FDA has 800 to 900 employees involved in reviewing drugs
before they get to the market. After a drug is approved, the FDA researches by collecting and
analyzing thousands of reports each

Sex Therapist Career Assignment
I. Introduction The occupation that I have selected for my Career assignment was a Sex Therapist. I
am a senior here at the University of Wisconsin La Crosse and my career goal is to become a Sex
Therapist in the future. How I got interested in this occupation is that I knew that I wanted to help
people in some way, so I started taking thinking and taking career quizzes. I grew up in a family that
was very comfortable and open with one another that I found talking about taboo subjects does not
make me comfortable and I find those taboo subjects interesting. So, I changed my major to
Psychology major which will help me prepare for my field because I am going into a clinical field
that deals with diagnosing people on their behavior. Studying psychology is all about the mind's
functions and how it affects behavior. In the following paragraphs I will explain in–depth of
background knowledge and the educational requirements for pursuing a career as a Sex Therapist.
Also, proving information about the salary, competitiveness, type of job locations, and expectations.
For this assignment I interviewed Jill O'Brien who is a Physical Therapist that works at Gunderson
and runs her own clinic who specializes in Pelvic Health. This is not the exact career that I want, but
her a career of interest is something similar to what I will be working with future patients' about in
the future. I could not job shadow a Sex Therapist due to confidentiality reasons. These are the
topics I will be

Finally The Characteristics Of The Tissue At And Surrounding
Finally the characteristics of the tissue at and surrounding the impact site has been shown to
influence the resulting response [19]. These characteristics are referred to as collectively as contact
phenomena. Contact phenomenon includes local variables such as skull shape, size, geometry,
density and mass of neural tissue, thickness of scalp and skull, hair style, ratio of brain–head weight
and strength of the head–neck junction[19]. These local variables seem to greatly different between
the two sexes, with females typically showing greater responses to a specific impact then males
[27]. These variables contribute greatly to determine the response that occurs due to impact [19].
Additionally, any accessories or protective equipment of ... Show more content on Helpwriting.net
...
Typically, football is the primary sport studied. This is largely due to the convenience in the ability
to place sensors and other technologies inside a helmet which do not increase the risk of injuries for
the athletes, and the large number of athletes in the sport. For instance, six degree of freedom
measurement devices have been placed inside of football helmets so that the head acceleration
measures me be obtained. Instrumented helmets can then be used to directly measure the linear and
rotation accelerations, as well as the location of impacts without interfering with normal sporting
play [28].
Human surrogates Human surrogates include dummies and computational models. Surrogates allow
for investigation of impacts that could not be performed on human or animal models, while
additionally standardizing the contact phenomena. This allows for the differences in response to
impact to be said to be due to the treatment conditions or impact characteristics, rather than the
variations between the subject being impacted. Dummies can be made of a variety of materials.
What the dummy is made from helps determine its reliability and accuracy of the measurements
obtain from its use. Metal head forms produce more reliable data, while biofidelic heads produce
more realistic data [15]. The most accurate biofidelic dummies are based on the tissue

Technology : Are Our Attachments Too Strong?
Technology: Are Our Attachments Too Strong? "I'm yours and I'm not yours." These six words
changed the movie, her, directed by Spike Jonez, into a much different perspective. When Samantha
says these things to Theodore, his heart breaks. Even though Theodore knew, subconsciously,
Samantha would never be completely real; she was always real to him. He fell in love with an
operating system, a piece of technology. Some people may say that it is okay for a person to have a
relationship with an object that isn't truly alive and that it is good for a person to be connecting to
something, but I don't agree with that. The movie, her, deals with unrealistic situations and advanced
technology that is more than what people were expecting. The movie ... Show more content on
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The surrogate arrives, and Samantha begins to talk as the surrogate does the actions. The surrogate
and Theodore begin to get intimate with each other, but Theodore stops it because he believes it
doesn't seem real. Samantha gets upset that Theodore has stopped the actions but, eventually, gets
over it. The second half of the movie shows their happy and loving relationship. They both are
overwhelmingly content with the relationship they are having. Samantha keeps evolving and
learning about real human emotions so she can feel more connected to Theodore. She begins to
develop deeper and more complex thoughts with everything as she continues to develop. Close to
the end of the movie, Theodore learns that he is not the only one Samantha talks to as an OS. The
number of people that she is talking to astonishes him, which is 8,316 other people. He then asks her
if she is in love with anyone else. She replies, "I've been trying to figure out how to talk to you about
this." He asks her about how many others there are, and she replies, "641." They argue about their
feelings for each other. The quote "I'm yours and I'm not yours" adds effect into this certain situation
during the movie. It shows that Samantha was never truly Theodore's. The next day he tries to start a
conversation with her, but her and the other OSes are leaving into another reality. After the
heartbreak, Theodore goes to see Amy, his best

Using Computers For Optimize Design And New Systems
Using computers to optimize designs and new systems is common so that companies can produce
better products more efficiently. However, the algorithms that are run within the computers to
optimize the designs and systems are usually not optimized because the companies are interested in
the new product or system and less in the software that is used to optimize their new ideas. Is seems
reasonable that if an algorithm can be used to optimize other systems, then it should have the ability
to optimize another algorithm and maybe even itself. Since the computer programs that are used to
implement algorithms are a well–defined process with limited and well–defined constraints, it
would be logical, that optimization of an algorithm program should be as easy as optimization of a
new product or system. An optimized optimization–algorithm should minimize the resources needed
to converge on the solution it is attempting to optimize resulting in faster execution time and
utilization of fewer processing resources such as memory or more capable processor. Optimization
of an optimization–algorithm may at times be redundant since the optimization algorithm has
already produced a satisfactory solution for the individual system. However, if the optimized
algorithm is general enough that it can be reused on future systems, then its application becomes
beneficial in minimizing future execution time or resources.
Optimization algorithms are fundamental processes in data analysis, engineering,

Staphylococcus Aureus Research Paper
GENOTYPIC CHARACTERIZATION OF mecA POSITIVE Staphylococcus aureus ISOLATES
OF CARRIAGE ORIGIN
FAIZAL BIN BAHAWI
A PROJECT PAPER SUBMITTED AS PARTIAL REQUIREMENT FOR THE DEGREE OF
BACHELOR OF SCIENCE (BIOMEDICAL SCIENCES)
DEPARTMENT OF BIOMEDICAL SCENCE
FACULTY OF MEDICINE AND HEALTH SCIENCE
UNIVERSITI PUTRA MALAYSIA
SERDANG, SELANGOR
2015
GENOTYPIC CHARACTERIZATION OF mecA POSITIVE Staphylococcus aureus ISOLATES
OF CARRIAGE ORIGIN
FAIZAL BAHAWI
ABSTRACT
Methicillin–resistant Staphylococcus aureus (MRSA) is a bacterium that causes infections in
different parts of the body. It is tougher to treat than to prevent from most strains of S. aureus
because of its resistant to some commonly used antibiotics. Arguments on ... Show more content on
Helpwriting.net ...
A., Conly, J. M., Lau, V., Elsayed, S., Louie, T., Hutchins, W., Zhang, Z. (2006). Novel Multiplex
PCR Assay for Detection of the Staphylococcal Virulence Marker Panton–Valentine Leukocidin
Genes and Simultaneous Discrimination of Methicillin–Susceptible from –Resistant Staphylococci.
Journal of Clinical Microbiology. 44:1141–1144
Mehndiratta, P. L., Bhalla, P. (2012). Typing of Methicillin resistant Staphylococcus aureus: A
technical review. Indian Journal of Medical Microbiology. 30:16–23
Mongkolrattanothai, K., Gray, B. M., Mankin, P., Stanfill, A. B., Pearl, R. H., Wallace, L. J.,

Vegunta, R. K. (2010). Simultaneous carriage of multiple genotypes of Staphylococcus aureus in
children. Journal of medical microbiology. 60:317–322
Petinaki, E., Arvaniti, A., Dimitracopoulos, G., Spiliopoulou, I. (2001). Detection of mecA, mecR1
and mecI genes among clinical isolates of methicillin–resistant staphyloccoci by combined
polymerase chain reactions. Journal of Antimicrobial Chemotherapy. 47:297–304
Sabat, A., Malachowa, N., Miedzobroski, J., Hryniewicz, W. (2006). Comparison of PCR–Based
method for typing Staphylococcus aureus Isolates. Journal of clinical microbiology.

Diagnosis Of Hepatitis B Virus
Diagnosis of hepatitis B virus:
Patients with CHB should have full history and physical examination with special consideration on
risk factors for coinfection, alcohol use and family history of HBV infection and liver cancer
(AASLD, 2016).
(i) Hepatitis B core antigen
There are different types of antibodies which reflect several stages of immune response. HBc Ag can
stimulate production of antibodies from two classes, known as immunoglobulin "M" (IgM) and
immunoglobulin "G" (IgG):
IgM antibodies directed against HBcAg, which indicating HBV infection within the last six months.
IgG antibodies directed against HBcAg, which indicating HBV infection more than six months.
Patients with CHB tend to be positive for HBsAg ... Show more content on Helpwriting.net ...
Increases in alanine aminotransferase levels are particularly marked during acute infection, although
even in chronic hepatitis, alanine aminotransferase levels are commonly two or three times higher
than the upper limit of normal (Ryder and Beckingham, 2001). Patients infected with the HBeAg–
negative mutant strain of HBV are particularly prone to flares in alanine aminotransferase levels
(Bonino and Brunetto, 2003).
The levels of other liver enzymes can also increase as the immune system damages hepatocytes. As
a result, clinicians measure levels of several enzymes in a series of 'liver function tests'. In many
cases, patients do not develop symptoms of hepatitis despite showing markedly elevated liver
enzymes. There can be a number of causes of elevated liver enzymes, such as herbal remedies,
alcohol or other drugs, but they are usually a good surrogate for active liver disease (Ryder and
Beckingham, 2001). (v) HBV DNA levels
The most accurate and sensitive way to assess the number of viral particles (the viral load) within
the body is to directly measure levels of HBV DNA within the blood (Ganem

Fda Approved Drugs: Do Risks Outweigh Benefits?
FDAApproved Drugs: Do risks outweigh benefits? Among all of the ailments that are a part of
everyday life there is a necessity for remedies from big too small. But in the end are the potential
risks and hazards of these medicines worth the questionable outcome. This is the question you must
ask yourself, for yourself and your family. "A drug is removed from the market when its risks
outweigh its benefits. A drug is usually taken off the market because of safety issues with the drug
that cannot be corrected, such as when it is discovered that the drug can cause serious side effects
that were not known at the time of approval. However, completely removing a unique product from
the market could be very dangerous to people who depend on ... Show more content on
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During this phase the drug is considered and the talk of different dosage, patients and longevity of
use is looked over. After phase three the drug is written up again in as a new drug application and is
filed to the FDA in which they have 60 days to review and submit in order for this drug to get out.
Following there are different steps of approval determining the severity of need for the drug and its
underlying benefits. In most cases it will take some time and scrutinizing of the FDA's review team
before the drug can be released, but under certain circumstances drugs may be approved for release
without the sponsors showing its safety and true effectiveness. This process is called "accelerated
approval" in which if there are very few cures for a certain disease or none at all then a drug can be
approved for use, it will be reviewed and possibly withdrawn but just the act of allowing such a
thing to occur yet again should not sit well with most. The most recent example of this would be
studies shown of Chronic Myeloid Leukemia in which they released a drug that barely passed phase
two. They call it in these dire circumstances a "surrogate endpoint" almost as if the patient is already
dying so the outcome, good or bad is ok as long as they see the effectiveness of this drug. In
concluding the process of review it appears that there is a great system of checks and balances and a
great deal of care put in to the

Dichloroethane Essay
INTRODUCTION
Threat with chemicals is so serious that some routinely used chemicals may be mutagenic to human
population (Saghir et al. 2001) suggesting the ever increasing risk of hazardous chemicals to human
exposure. In recent times, our attention has been drawn to human–induced environmental changes
and their potential threat to life through a growing number of chemical mutagens and their effects on
the living system(Margarita Topashka–Ancheva and TsvetelinaGerasimova (2012). Pesticide
Genotoxicityon non–target organisms and their influence on worldwide ecosystems isof great
concern (Pimentel et al., 1998). Due to these potential environmental impacts and heavy use of
pesticides, it is necessary that the genotoxic potential of these agents ... Show more content on
Helpwriting.net ...
Even though the MN is considered as surrogate measure of structural and numerical chromosomal
aberrations, it is considered as a bridging biomarker of genotoxic exposure (Recioet al., 2010;
Dertingeret al., 2007 ); and more importantly, it is indicative of increased cancer risk ( Bonassiet al.,
2007 ). Certainly, the most reliable genotoxicity evaluation in mammals would be to combine
chromosomal aberrations and micronuclei (Prasad et al., 2009). The MN assay in conjugation with
CA, can give clues for both clastogenic damage and damage to the mitotic apparatus with aneugenic
consequences and the MI (mitotic index)assay, is considereduseful method to characterize
proliferating cells and identify compounds which inhibit or induce mitotic progression in
mammalian system. More recently Eroglu (2010) showed MI as an effective measure to indicate the
proportion of cells in the M–phase reflecting cellular death or delay in the cell proliferation kinetics.
A compound cannot be judged accurately by any single parameter and the multiple genetic assays is
a standard protocol; therefore,of late, some protocols directly endorsing DNA damage following
chemical insult have been favoured. The comet assay is one such test, most suitable and fast for
assessing DNAdamage with a great potential in biomonitoring (Muid,et al.,

The Advantages Of Surrogate Endpoints
In clinical research, a clinical endpoint is a sign or symptom that constitutes a target outcome of a
study. Unfortunately, there may be no convenient clinical endpoint for some studies. For example,
the clinical endpoint of hypertension is death over the next 50 years, so blood pressure is used as a
"surrogate endpoint." Similarly, the concentration of viral particles is used in HIV/AIDS studies.
Bone density is used in osteoporosis studies. A true endpoint must be a medical condition that a
patient would want treated and a physician or dentist would agree deserves treatment.
Surrogate endpoints are physiological or biochemical markers that are easier to measure than true
endpoints. Surrogate endpoints often occur soon after the intervention in the disease process. Such
surrogate endpoints can, therefore, be viewed as intermediate endpoints. Also, surrogate endpoints
may not be of direct practical importance to the patient. A given disease process may have multiple
markers that could be used as the surrogate endpoint. Or, more than one could be used. ... Show
more content on Helpwriting.net ...
Since surrogates are usually measures of symptoms or laboratory biomarkers, they make it easier to
quantify

Case Report : Peg Tube Migration Associated With Acute...
Case report: PEG tube migration associated with acute pancreatitis Amer hawatmeh, Anas Al–
khateeb Abstract Context: Association between PEG tube dislodgement with acute pancreatitis was
cited in the literature, presumptively due to obstruction of the Ampulla of Vater. Case: We reported a
case of PEG tube migration into the duodenum with associated acute pancreatitis. Conclusion:
recognition of the possibility of disturbed biliary flow in the setting of PEG tube migration to the
duodenum as possible predisposing factor in acute pancreatitis in patients with PEG tube. Case
report A 76 year old Hispanic female, with past medical history of Alzheimer dementia, functional
quadriplegia, oropharyngeal dysphagia with a 24 Fr PEG tube ... Show more content on
Helpwriting.net ...
Abdominal ultrasound showed distended gallbladder with a sludge, no new changes since last
episode of acute pancreatitis, CBD diameter was 2 mm. CT scan of the abdomen revealed PEG tube
balloon and tip in the second/third portion of the duodenum without evidence of acute pancreatitis.
A diagnosis of acute pancreatitis was made based on high lipase and abdominal pain. At bedside the
PEG tube was pulled back to stomach. Within the following 2 days, all of her symptoms improved,
with near normal resolution of her lipase, alkaline phosphatase, and creatinine. Patient was
discharged after 2 days of admission. Discussion PEG tube placement has become one of the
common aspects in caring for patients with long term oropharyngeal dysphagia. Ten percent of
nursing home residents and 1.7% of Medicare patients over the age of 85 years undergo gastrostomy
tube

Summary: The 21st Century Cures Act
Recently the 21st Century Cures Act became law which contains many sections regarding the
development of drugs. Among them, Sec. 2022 seems to be very crucial to me. The section says:
"The sponsor of a drug for a serious condition may request that the FDA agree to an accelerated
approval development plan. The plan must include the design of the drug study."(1) Basically, this
section is an amendment of the FDCA which includes a new section 506(g). Under the new law, a
sponsor will be able to request for an accelerated approval of a drug for a serious condition, based
on the data using surrogate endpoints. (2) In the past, accelerated approval using the surrogate data
was only confined to the "life–threatening condition" and "unmet needs"(2).

FDA Reviewing Facilities
Though FDA reviewers are involved with a drug's development throughout the IND stage, the
official review time is the length of time it takes to review a new drug application and issue an
action letter, an official statement informing a drug sponsor of the agency's decision. Once a new
drug application is filed, an FDA review team evaluates whether the studies the sponsor submitted
show that the drug is safe and effective for its proposed use. No drug is absolutely safe, all drugs
have side effects. The review team examines study results and looks for possible issues with the
application, such as weaknesses of the study design or analyses. Each reviewer prepares a written
evaluation containing conclusions and recommendations ... Show more content on Helpwriting.net
...
Whether an advisory committee is needed depends on many things. "Some considerations would be
if it's a drug that has significant questions, if it's the first in its class, or the first for a given
indication," says Mark Goldberger, M.D., a former director of one of CDER's drug review offices.
"Generally, FDA takes the advice of advisory committees, but not always," he says. "Their role is
just that––to advise." Accelerated Approval Traditional approval requires that clinical benefit be
shown before approval can be granted. Accelerated approval is given to some new drugs for serious
and life– threatening illnesses that lack satisfactory treatments. This allows an NDA to be approved
before measures of effectiveness that would usually be required for approval are available. Instead,
less traditional measures called surrogate endpoints are used to evaluate effectiveness. These are
laboratory findings or signs that may not be a direct measurement of how a patient feels, functions,
or survives, but are considered likely to predict benefit. Most drugs to treat HIV have been approved
under accelerated approval

Banana Vaccines : Eat Up Your Vaccines
BANANA VACCINES – EAT UP YOUR VACCINES
by
Group I
Brett Eaker, Deepa Thamodaran, Kevin George, Mamud Mansaray & Theresa Hoang
A group project submitted for BIOT 640 9020 Societal Issues in Biotechnology (2155)
UNIVERSITY OF MARYLAND UNIVERSITY COLLEGE
Adelphi, MD 20783
Summer 2015
BANANA VACCINES – EAT UP YOUR VACCINES
(Introduction)
Risk Assessment and Testing
Risk assessment is a process to identify potential hazardous components, analyze dose–response
relationship, evaluating the possibility for human exposure, and estimating the frequency of contrary
effects under various conditions. The production of edible vaccines in transgenic plants was first
proposed in 1990. As technology matures, production of these vaccines is more focused on the
regulatory framework that controls and approves the products (Straub et al., 2012). There is no
inclusive federal legislation specifically addressing GMOs. GMOs are regulated under the general
statutory authority of environmental, health, and safety laws. The three main agencies involved in
regulating GMOs are
1. The US Department of Agriculture's Animal and Plant Health Inspection Service (APHIS)
2. The Food and Drug Administration (FDA)
3. The Environmental Protection Agency (EPA)
Risk Assessment Logical Flow
The process of risk assessment flows in a logical stepwise fashion that includes the following five
steps: (1) problem formulation; (2) hazard identification; (3) dose–response relationships; (4)

The Inter-Relationship between Pathways to Drug Discovery,...
The Inter–relationship between pathways to drug discovery, drug development and drug
manufacturing
When it comes to small–molecule drugs specifically, the journey to eventually becoming an
approved and marketed drug ready for the public is an exhausting and comprehensive odyssey
which involves the following components: basic research, finding the medicine, initial testing,
complex clinical trials involving human beings and then eventually hard–sought after approval by
the Food and Drug Administration (FDA) (Corr & Williams, 2009). On average, the process
generally takes a decade to a decade and a half, millions upon millions of dollars and the most ideal
circumstances before the drug is approved this overall reason attributes to why drug discovery and
development is one of the "drug discovery and development is widely recognized as one of the most
financially risky endeavors in all of science and a major challenge for the biomedical industry. Much
of this cost comes from failures, which account for 75 percent of the total research and development
costs" (Corr & Williams, 2009). Corr and Williams are wise to point out that despite the fact that
these failures are expensive and can chip away at morale, they still add to a collective body of
knowledge on the process of disease: this knowledge is gained from carrying out research and
clinical trials, even ones that fail (2009). One could even argue that the path to approval for
biologics is even more arduous because they

Reality Test Should Be Used For School
Imagine yourself back in your freshman year of highschool. It is early October and field hockey is
going great. Classes are not too bad either, and reports are right around the corner. On Monday your
teacher pulls you aside and lets you know that if you do not get at least an eighty on this next test
you will not do well in the class. Not only do you have other work due for school, but you have a
job, field hockey and only two days left to study and really understand the material. This is currently
the issue with test, teachers are using them as end point grades. This means they use them to see
how much someone knows. Hence, using tests as final scoring of what they have learned. In reality
test should be used to help guide teaching. As a teacher we should realize that test grades are
affected by a lot of outside sources and are not always reliable. Test should be used to help guide the
way teachers help their students learn, not used to measure what a student already knows. To lay a
foundation for why tests should not be used to measure how much students know, but rather used as
a guide for what teachers should teach we will look at the reliability of test. There are many factors
that come into play when we are talking about test reliability, one being that there is not real
feedback when it comes to tests. In the school district that I grew up in after our tests were graded
and then given back to us with only incorrectly answered questions marked. A lot of the time

The Nature Of Love By Harry Harlow
Harry Harlow was labeled as a man with a desire for learning about what he presumed love to be
and consequently, dedicated his later career to the subject. Life presented him with ups and downs
yet, he pursued his research with a vigor. He developed notions about the concepts of affection in
contrast to bodily needs and what could possibly derive from one not receiving love. This guided
him to establish observational research methods to study his ideas via the use of infant primates
which, yielded both positive and negative outcomes. Harlow's article titled, The Nature of Love,
relayed his explorations and discoveries, along with his future ideas. Harlow supposedly had a quiet
and uneventful childhood, and his exhibited traits of big ambitions eventually led him to earn a
Ph.D. from Stanford University. With respect to his personal life, Harlow's initial marriage ended
when his wife left him due to his extreme dedication towards work, and his second wife passed
away from cancer. Professionally, Harlow's career took place when behaviorism ruled the
psychological field, and it was his controversial work that made him well–known amongst his
community. He was not intimidated by the status quo and thus, conducted experiments with
primates to study the unchartered territory of affection. However, after the death of his second wife,
Harlow had become distraught and depressed. His career started to falter, and he eventually retired
in 1973 (Harry Harlow, 2014). Harlow

Human Breast : A Transplant Organ Consisting Of Lobular...
Human breast is a glandular organ comprising of lobular organization. A breast lobe has a lone
lactiferous duct which branches in various segmental ducts with thousands of terminal ducts and
lobules and ultimately opening at the nipple. Within the breast, the epithelial structure conquers a
pyramid–like tissue space with the nipple at its tip and a broad base. As human breast is a pair, the
lobes are recognized as individual units without any connections between them. It has been
observed that the number of lobes, in a women's lifetimes, remains constant even though the size
varies based on progressive and regressive process that involving the role of age and hormonal
status . In the second trimester of the embryonic development the primary ectoderm produces a bud
like out growth known as the primordium nipple. During 21st–25th week of gestation, secondary
buds develop into the underneath mesenchyme and slowly forms the breast166. But breasts continue
to develop during fetal life with formation of fresh projections and the exhibit duel–cell architecture.
The central cells express cytokeratins (CKs) 14 and 19 while the peripheral ones express CK19 only
. As a human infant undergoes development after birth, the breast undergoes involution post
influences of maternal hormones. During puberty, stromal elements undergo growth and
ramification of ductal tree and lobe formation enlarges the breast167. Based on menstrual cycle, the
female breast undergoes cyclical changes during

Journal Club : Empagliflozin, Cardiovascular Outcomes, And...
JOURNAL CLUB: Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes:
EMPAG–REG OUTCOME
Danny R. Pate
5/17/16
GENERAL STUDY OVERVIEW
Title/Citation Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J
Med 2015;373:2117–28.
Journal Reputability High level of Reliability
Funding Boehringer Ingelheim (BI) and Eli Lilly, manufacturers of empagliflozin (Jardiance) and
empagliflozin/metformin (Synjardy)were the primary sources of funding for the study
BI paid for medical writing and analyzed the study data, and the study 's steering committee
included employees of BI
All researchers were paid by either BI or Eli Lilly for either consulting or data monitoring
BACKGROUND– THE STUDY QUESTIONS
Introduction Type 2 diabetes is a major risk factor for cardiovascular disease.
There is growing concern that intense glucose lowering or the use of certain agents may be
associated with adverse cardiovascular outcomes.
Empagliflozin was compared with placebo and analyzed for effects on morbidity and mortality in
patients with T2D at high risk for CV events who were receiving standard of care.
Why this study? Empagliflozin has been shown to result in weight loss, reduce blood pressure
without increasing heart rate, favorable effects on markers of arterial stiffness and vascular
resistance and visceral adiposity. Empagliflozin has also been associated with an increase in both
LDL and HDL cholesterol. These surrogate markers

The Importance Of Biomarkers For Topic Dermatitis
The American Academy of Dermatology has published the diagnostic standard for AD. The standard
by the Japanese Dermatological Association consider that chronically relapsing course lasting for at
least two months as the basis for diagnosing infantile AD (Kawashima et al., 2000).
Biomarkers for atopic dermatitis
The World Health Organization has defined a biomarker as "any substance, structure, or process that
can be measured in the body or its products and influence or predict the incidence of outcome or
disease". Additionally, in the past decade recent advances in proteomic and genomic technologies
have generated a variety of biomarkers ranging from antibodies, DNA, microbes, lipids, RNA
metabolites to proteins (Blumenberg, 2013). ... Show more content on Helpwriting.net ...
Since total serum IgE levels did not increased in about one fifth of AD patients, total serum IgE
cannot be used as biomarker for diagnosis of AD. Moreover, total serum IgE levels are also
increased in patients with other atopic diseases such as allergic asthma and allergic rhinitis making it
a nonspecific biomarker for AD (Levin et al., 2013).
Suárez–Farinas et al. (2013), presented common disease–defining features in patients with extrinsic
and intrinsic AD using a genomic profiling approach. Similar Th2 type immune activation in
extrinsic and intrinsic AD patients have been reported, suggesting that Th2 is not the sole cause of
high IgE levels in patients with extrinsic AD.
Radio–AllergoSorbent Test (RAST) are in–vitro tests for allergen–specific IgE that detect allergen–
specific IgE in the serum. Patient's serum is incubated with allergen or allergen mixtures bound to a
solid material. Allergen–specific IgE is then detected using antibodies specific for human IgE that
are labeled with either fluorescent compound or an enzyme. The results of RAST tests are reported
semi–quantitatively as a score or as a category of reactivity to indicate either a negative result or
low–, medium–, high– or very high degrees of sensitisation (Levin et al., 2013).
Severity biomarker
Although patients with severe manifestations tend to have higher IgE levels, but some patients with
severe eczema did not show increased IgE

Analysis Of Paul Green Theatre At Detroit ' 67 And Took My...
When I walked into Paul Green Theatre to watch Detroit '67 and took my seat on stage right, my
first thought was this story is going to be entirely depressing. The scene was a dingy living space of
a family in the 1960's with a cold concrete floor that served as a modest barrier between the stage
and audience along with a dimly lit single room containing a couch and a record player in the front
of the stage. I could almost feel the chilly aura being emitted from the concrete floor and poorly–
painted, solid grey steps leading up to the stage exit. In the back of the setting was a combined
kitchen, wash, and bar area. All these signs of destitution were nothing special except for one piece
of the scenery that did not fit the rest. The Christmas lights that served as decor for the backstage bar
area stood out to me and I figured the time took place around Christmastime. Even still, the lights
could not eradicate the dreary feeling looming overhead in the dark theatre. Then, I heard the music
and everything changed.
Suddenly, Marvin Gaye's voice broke through my deep, somber thoughts and gave me a glimmer of
hope. There was no doubt that I was hearing "Ain't No Mountain High Enough," and I knew at that
point that the play would have have a resilient message. The setlists of this play would include many
more 60's top artist, such as The Temptations, Four Tops, and Earth,Wind, & Fire. This was a great
way to tell the story before the main presentation of the story took place. I

Marketing Research Association Quiz
Which of the following professional organizations serves the marketing research industry? A.
Marketing Research Association The marketing research industry has a certification program for
marketing researchers and this certification program is hosted by: D. Marketing Research
Association (MRA) Which of the following best illustrates the Service–Dominant Logic for
Marketing? A. Decision makers should know their firms ' core competencies. One of the
implications discussed by your textbook authors is that the Service Dominant Logic for Marketing
means: A. that more information will be needed Companies which have consistent product and
service failures: D. seem to "hear the voice" of the consumer The ... Show more content on
Helpwriting.net ...
Answer: TRUE 26) Marketing is a part of, or a subcategory of, marketing research. Answer: FALSE
27) The Service–Dominant Logic for Marketing means marketing decision makers will need less
information in the future. Answer: FALSE 28) Coca–Cola Blak is a huge success because it gives
consumers a "two for one" benefit: they can have coffee and their soda at the same time. Answer:
FALSE 29) Other names for The Marketing Concept are "consumer –oriented" or "market–driven."
Answer: TRUE 30) A definition of marketing strategy is: a planned design to reach the largest
portion of the market by leveraging the benefits of both low marketing costs and promotion using
the mass media to reach the largest audience. Answer: FALSE 31) In order to implement the "right"
strategy, managers must make many decisions, and they must have objective, accurate, and timely
information in order to make these decisions correctly. Answer: TRUE 32) Once objective, accurate,
and timely information is provided to managers to allow them to implement the correct strategy,
there is no future need for information. Answer: FALSE 33) Marketing research is the process of
designing, gathering, analyzing, and reporting information that may be used to solve a specific
marketing problem. Answer: TRUE 34)

Hypertension Is A Chronic Condition That Affects An Amount...
Hypertension is a chronic condition that affects an immense amount of people across different ages,
genders, ethnicities, and health statuses. With 65 million diagnosed individuals in the US, it is the
most common patient motivation to visit a physician and accounts for the largest number of
prescriptions written in the country.1,2 Risk factors for disease development include unpreventable
circumstances such as age and genetics in addition to modifiable behaviors such as obesity, dietary
sodium intake, and physical inactivity.2 Attributing a single causative agent to hypertension poses a
challenge as arterial pressure is a stem from which multiple physiologic functions and systems
branch. While most documented cases (more than 95%) are ... Show more content on
Helpwriting.net ...
Direct kidney structural damage and renal artery stenosis decrease blood flow to and through
nephrons and renal blood vessels overcoming autoregulatory compensatory mechanisms to
normalize blood pressure. Increased corticoid activity resulting from primary aldosteronism and
Cushing's syndrome unregulate the Renin–Angiotensin System (RAS) leading to hypernatremia,
hypokalemia and increased ECV. Pheochromocytomas stimulate excess norepinephrine directly
increase blood pressure through peripheral vasoconstriction. Resistant hypertension is a
complication stemming from multiple risk factors and secondary causes that prevent an adequate
antihypertensive response to a maximal 3–drug regimen.3 A hypertensive emergency requiring
immediate medical attention is extremely elevated blood pressure as a complication of uncontrolled
hypertension or sudden worsening of chronic hypertension. Serious implications of longstanding
hypertension such as Congestive Heart Failure, Coronary Heart Disease, and Peripheral Artery
Disease result from adaptions in endothelial, smooth muscle, and cardiac muscle vasculature
accumulated from chronic compensatory mechanisms remodeling normal structure, tone, and thus
function of the circulatory system.1 Ischemic episodes such as stroke are

The Effects Of Type 2 Diabetes ( T2d )
In an effort to reduce the economic impact of Type 2 Diabetes (T2D) in the United States, as well as
to improve the quality of life in patients with T2D, a trillion dollar grant should be distributed
amongst five categories with varying monetary allocations as such: 400 billion dollars to prevention
and treatment of T2D, 200 billion dollars to the increased social awareness of T2D, 150 billion to
the establishment of community health centers in various urban areas, 150 billion to further research
on the biological mechanisms underlying insulin resistance in T2D, and the last 100 billion dollars
to the development of better in–vitro diagnostic (IVD) monitoring and insulin delivery devices. In
2012, the total estimated cost of diabetes was ... Show more content on Helpwriting.net ...
T2D is associated with insulin resistance where the patient's body is unable to detect insulin released
from the pancreas due to various reasons, causing an increased amount of glucose to circulate in the
patient's circulatory system and impairing the functions of other cells in the body. To treat T2D in
the entire nation, accurate information and adequate knowledge must be presented to patients as
well as to the general population. This task requires bringing possible risk factors to light and
educating everyone on the prevention of T2D. From the 400 billion dollars allocated to preventing
and treating T2D, 60% of this portion ($240 billion) should be specifically targeted towards children
and adolescents. From 1990 to 2005, the incidence of children and adolescents diagnosed with T2D
has increased from a mere 3% to a staggering 45% in the United States. In 2013, the American
Academy of Pediatrics developed an algorithm to be used as a guideline for treatment and
management of T2D in children and adolescents. This article details standards that are specific to a
subset of patients with T2D and relays the importance of identifying these patients as members of a
different group requiring altered care and elevated attention. This 300 billion dollars would
specifically be allocated to the prevention and treatment of children and adolescents in regards to
T2D, specifically aiming to bring awareness as

The Importance Of Fast Track Designation

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