Clinical Pharmacology Assignment: Vaccine, Ulcers, and Cancer Details

This assignment delves into key areas of clinical pharmacology. Section A discusses the accelerated development of COVID-19 vaccines, contrasting it with conventional methods and exploring various vaccine strategies, including inactivated pathogen, protein subunit, viral-vectored, and nucleic acid vaccines, along with their advantages and disadvantages. It also compares and contrasts the roles of antihistamines in treating allergic inflammation and peptic ulcers. Section B examines the modes of action of cell cycle non-specific (CCNS) and cell cycle specific antineoplastic drugs, providing examples for each class. The assignment concludes by discussing the relationship between proto-oncogenes and tumor suppressor genes and the cancers they are associated with, offering a comprehensive understanding of pharmacology in disease treatment and prevention.

CLINICAL
PHARMACOLOGY

SECTION A
Question 1:
a) Discuss how the accelerated COVID-19 vaccine developmental stages has helped to design
and develop a vaccine. How would it differ from the conventional vaccine developmental
process
The Covid-19 vaccine is basically used to prevent infectious diseases and also useful for
protecting from polio, influenza, hepatitis B. when most of the people in community are
protected by vaccination, identify the ability of pathogen to spread among people. Usually,
infectious spread can be occurred in both indirect or herd in large populations. Some kind of
people have a better immunity, indirectly protects individual people who cannot be vaccinated.
The covid-19 vaccine developmental stages are basically depending on the current
situation so that it may be increased the speed of vaccine development.
Here are described about the Vaccine development stages-
 Preclinical stage- in this phase, it is mainly focused on the research intensive and find
natural or synthetic antigens. These kind of substances are including an immune reaction
in human body. Afterwards, it is trigger the similar reaction on covid-19, identifying the
actual reaction of antigen but sometimes, it takes time to generate a positive result or
outcome.
 Phase-1 and phase-2 Trail- it is second stage in which perform testing at first time.
Usually covid-19 vaccine is tested in small group of people such as adults between ages
of 20 to 80. Afterwards, it is also measured the immune response and phase -2 aim is to
find the most effective dose and expand safety experience with experience. Researchers
look for expected to find out the reaction to the vaccine and it could be include
anticipated adverse events such as redness, muscle, headache, swellings at the time of
injections. Phase-1 and 2 trails are becoming consider an important aspect in which
perform the different steps while receiving the vaccines. In case of covid-19, The vaccine
can be undertaken to measure its effectiveness among human beings.
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 Measure the effectiveness of vaccine- once phase-1 and phase-2 trail completed, it is
moved to another stage, and focus on the different participants of volunteers where they
can receive vaccine whether it is effective or not. On the basis of measurement, medical
professionals are investigating the SARS-COV-2 vaccine. It can be performed the testing
on thousands of people. Afterwards, It would check the vulnerability of covid-19 in areas
where it has been rapidly increasing the transmission from one person to another.
 Regulatory approval- it is very important phase in order to take some approval from
government, manufacturer’s sides. After successful completing phase-3 trails, it has been
submit the application to other regulatory. In this way, it can easily review the actual data
or information of vaccine trails, make sure that vaccine is safe and effective. Once the
vaccine is approved, it is enough of item which needed to be manufactured and find the
immunize those are required. On the basis of demonstrate, it can be concerned about the
supply of vaccine doses worldwide.
 Develop or create road map for vaccine safety- it is last phase of vaccine design and even
when covid-19 has been successfully approved. The regulatory authority will provide the
license of manufacturer. Moreover, it involved the continuing to monitor, track the
production, inspecting manufacturing facilities. this is the best way to manage and control
the overall aspect of testing. Generally, The FDA will be monitoring the adverse events
which may occurs related to receive a vaccine. Phase-4 based on the clinical trials done
by testing companies. Additionally, it may be required to use the best platform and
promote the awareness among people in regards of vaccine. In some situation. It has been
licensed to track or monitor the all kind of safety or measurement aspects in proper
manner.
Ways in which it will differ from the conventional vaccine developmental process
The convention of vaccine development process is usually depends on the manufacturing
companies. If they were successfully developed or approved covid-19 vaccine. It may be reduced
the spread of infectious disease. In context of conventional vaccine, covid-19 vaccine has
developed which plays important role against the disease. But the vaccine made from the SARS
virus, which is already exists in the animals. The process of collecting, gathering virus but it is
important to adopt them in grow in lab. Afterwards, when emerging the virus such as SARS-cov-
2, it has been developed a new vaccine as per quickly. This is because it is very dangerous for
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large number of population, those are having a weak immune system. this virus is directly
affecting the respiratory system of human being.
On the other hand, the conventional vaccine aspect is that when growing large quantities
of virus so that it make sure that develop an effective vaccine. Therefore, no other kind of virus
can damage the immunity of person. by using vaccine, it has been injected the antigen like a
piece of virus, recognising the response of antigen. Afterwards, it has been monitored the
participation of anti-bodies and helping the person to fight against the covid-19
b) Discuss the various strategies used in the development of COVID-19 vaccines, commenting
on their potential advantages and disadvantages
There were various kinds of strategies that were used for development of Covid-19
vaccines and each of them had their own advantages and disadvantages, some of those strategies
have been explained below:
Inactivated pathogen vaccines strategies
PiCoVacc, CoronaVac were two types of Covid-19 vaccines developed using this
strategy. Covaxin was also developed using this strategy.
Advantages: it is one of the safest type of vaccine strategy that can be used as pathogen is dead
and its transportation and storage is also easier.
Disadvantages: large pathogen quantity is required to be processed. It do not produce cellular
response.
Protein Subunit vaccines strategies
Novavax is developed using this strategy.
Advantages: it is safe during production and can be safely administered
Disadvantages: It require several booster doses and even this strategy do not produce cellular
response.
Viral-vectored vaccines strategies
Chinese company CanSino Biologics used this strategy for development of Covid-19 vaccines.
Ad5-nCoV was one of the vaccine that was developed using this technique. Sputnik V is another
vaccine developed using this strategy.
Advantages: can help in inducing robust humoral and cellular responses within a single dose and
has good safety profile.
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Disadvantages: Pre-existing immunity against a human viral vector can attenuate immune
responses and storage required for this vaccine is at < −20 °C.
Nucleic acid vaccines strategies
This strategy has been adopted in development of SARS-CoV-2 Vaccine for
development of mRNA vaccines. One f the example of Covid-19 vaccine developed using this
strategy is Pfizer.
Advantages: scalability is one of the main advantage of this vaccine. Using this strategy vaccines
can be designed and developed as be developed in less time period and is extremely safe to be
used. Vaccines developed using this strategy have no chances of infection against handling.
Disadvantages: But this strategy has its own disadvantages such as: these vaccines require
special delivery platform. mRNA vaccines exhibit instability and require storage at < −20oC.
Question 3
Compare and contrast the role of antihistamines in treating allergic inflammation and peptic
ulcer
Role of Antihistamine in treating if allergic Inflammation-
Allergic Inflammation is one of the most common chronic condition, which is mainly
identified the patient’s life. It is not only causes the deterioration in the patient but it would be
increased the significant absenteeism. In order to reduce the level of productivity. In most of
cases, medical professionals are generally used the Antihistamine in order to control or manage
the allergic condition. it is one of the best treatment in order to influence with CNS and safety
aspect. In case, when medical professionals are prescribing the Ant-H1 drugs on the basis of
recommendation. Antihistamines are becoming consider as backbone of allergic disease
treatment. However, it is always available in the marketplace. When using this drug, it is directly
attacking on the allergic bacteria on human. It provide the pain relief where patient can feel so
much relax.
On the other hand, The primary role of Antihistamines are consistently effective for
symptoms relief in histamine or mediated disease. This is especially avoid any kind of harmful
effect on the human body. In order to reduce the level of anticholinergic side effects.
Antihistamines are combined with active metabolite with generate a positive result. This kind of
drug is one of the best option in order to use in the allergic treatment, demonstrated with inverse
agonism while reducing the downstream.
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Role of Antihistamine in peptic ulcer
In context of peptic ulcer treatment, Antihistamines are the best option in term of
medication that can be divided into different ways: H-1 and H-2 categories. H-1 antihistamines
which are mainly using for treatment of allergic symptoms. H-2 antihistamines can be used in
order to reduce the level of stomach acid, thereby, it helps to prevent the excessive amount of
acid in stomach. Therefore, it may be increased the chance of peptic ulcer. This type of disease is
very painful because a person can feel lot of pain. At that time, H-2 antihistamines Drugs are one
of the best option and recommend to the patient by medical professionals. As availability of
antihistamines at pharmacies, it server as dispensers but educators can purchase this kind of
medicine at the time of Ulcer treatment. It serve a crucial role in advising the patient where they
can use antihistamines at pharmacies. Each and every dose of medicines are very effective for
patient. but in most of cases, it may arise the cautions of any kind of contraindication, or adverse
side effect. Antihistamine drugs are generally used orally in a the form of tablet doses.
Sometimes, it can be reserved mostly for in patient where they can use for treatment of Ulcer and
allergic.
SECTION B
a) Compare and contrast the mode of action of Cell cycle non-specific (CCNS) antineoplastic
drug classes and Cell cycle specific antineoplastic agents with two examples for each class
Mode of action of Cell cycle non-specific (CCNS) antineoplastic drug classes:
 they are dependent upon cell being in a specific phase of cell cycle
 these are most effective in fast growing tumour that have a large proportion of cells actively
moving through the cell cycle and cycling at fast rate.
 This agent is dose dependent i.e. in this total number of doses given are more important as
compared to schedule.
 In this both proliferating and non- proliferating cells are killed.
 Even if these agents are given all alone they are highly effective so it can be given all alone
rather than in combination.
 It can be said that it is highly effective for both low-growth (solid tumours) and high growth
fraction malignancies.
 Two most common examples of this class are: Alkylating antineoplastic
agent and anthracyclins.
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Mode of action of Cell cycle specific antineoplastic agents:
 they are not dependent upon cell being in a particular phase of cell cycle for them to work.
they affect cell in all phases of cell cycle.
 They are most used as an effective drug in sow growing tumours in which resting cells are as
vulnerable as dividing cells to the cytotoxic effects of these agents.
 This agent is schedule dependent i.e. duration and timing are more important in this rather
than number of doses.
 In this only proliferating cells are killed.
 Works in much better and effective manner when it is given in combination rather than alone
 It can be said that it is highly effective for high growth fraction malignancies such as
hematologic cancers.
 Two most common examples of this class are: antimetabolites, antitumor antibiotic.
b) Discuss the relationship between proto-oncogenes and tumour suppressor genes and the
cancers they are associated with.
Relationship between proto-oncogenes and tumour suppressor genes
There is a strong relationship between proto-oncogenes and tumour suppressor genes. Both
of them are associated with each other or it can be said that are lined with each other, such as:
Proto-oncogenes are normal genes that help cells grow, whereas oncogene is any gene that
causes cancer. There are various kinds of proto-oncogenes and each one is responsible for
making protein involved in cell growth, division, and other processes in the cell and when this
proto-oncogene turns in a malfunctioning gene then it is called oncogenes i.e. proto-oncogenes
can become turned on when isn’t supposed to be turned on.one of the main property of cancer is
its uncontrolled cell growth which only because proto-oncogenes is involved in cell growth and
can turn into oncogenes when it is automatically activated. This explains Relationship between
proto-oncogenes and tumours suppressor genes is that when it contained oncogenes which is a
result of proto-oncogenes activation. Mostly, it is one of the main root causes of cancer, because
it automatically gets activated or inactivated. This mostly happens because when there are too
many copies of proto-oncogene then it can become bad gene because of which growth of cell can
become out of control which can lead to cancer. This is when these proto-oncogenes converts
into tumour suppressor genes. Tumour suppressor genes are also known as normal cell but on the
contrary they normally slow down the entire cell division slowly. In case, tumour suppressor
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genes does not working properly, it means that can grow out of control. In order to increase the
cancer disease condition.
Both proto-oncogenes and tumour suppressor genes have major difference between both
of them that further helps in understanding ways in which both of them are associated with each
other i.e., oncogenes is result of activation of proto-oncogenes, whereas tumour suppressor
genes can directly cause cancer when they are inactivated. Tumour suppressor genes have
Inherited abnormalities and is found in some family cancer syndrome. Due to this, Tumour
suppressor genes results in certain type of cancer that can run within families. But search in this
field have explained that most of the Tumour suppressor genes mutations are acquired and are
not inherited.
In context of cellular proliferation, it has been developed the stimulation functions and
related to the proto-oncogenes as well as oncogenes. These are two consider the functionality of
both and drive to measure the overall cycle. In most of cases, it has been identified the actual
condition of tumour suppressor genes because it has made of multiple layer of proteins.
Normally, it has been restricted to the actual growth of cellular and then divide or promote the
death. The problem may arise when it will be increasing the division of cell event but it is not
appropriately drive progress from one cell cycle stage to another.
Type of cancer proto-oncogenes and tumour suppressor gene are related to
Above explanation clearly helps in understanding relationship between proto-oncogenes
and tumour suppressor gene. proto-oncogenes example is Myc gene and it is associated a type of
cancer which is known as Burkitt's lymphoma when chromosomal translocation moves gene
enhances sequences close to Myc proto-oncogene. Whereas, INK4 and PTEN are two type of
tumour suppressor gene that are frequently mutated and type of cancer they are associated with
are: lung cancer, prostate cancer, and melanoma. APC and MADR2 tumour suppressor genes are
frequently deleted or mutated in colon cancers.
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