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Your Space - A 21th Century Pandemic
Since the beginning of human existence on planet Earth there has been one virus that has managed to pass through centuries and affec
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
t people all around the globe. It is known on all 5 continents as the the flu virus and, with the passing of time more and more info
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
rmation has been acquired giving scientists the possibility to create vaccines and medication.
Historical data shows the outbreak o
Historical data shows the outbreak o
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
f three major flu epidemics in the last century in different parts of the planet: Spain, Asia and Hong Kong. An epidemic affects a s
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ngle region, people or country without the possibility of outside spread of the disease. On the other hand, a pandemic-the major con
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
cern of modern society-has the ability to afflict millions of people in different parts of the world. So, the questions that come to
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
everyone's mind are: Can there be a modern pandemic? What will induce it?
Flu is caused by three viruses: A, B and C. The former
Flu is caused by three viruses: A, B and C. The former
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
s highly contagious and has the capacity to infect humans, birds and animals, while viruses B and C affect only people. The influenz
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
a A virus has been the starter point of flu epidemics in the past, managing to cause economical crisis on Earth. With the passing of
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
time virus A has become more powerful by developing new strains. The latest, the H5N1 virus which causes bird flu has been a major
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
source of rapid human loss of life due to respiratory diseases. This subtype is contagious and can be transmitted between different
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
species of birds or passed on to humans. For this reason, scientists worry the avian influenza may be the next pandemic to hit our p
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
lanet.
Firstly, the H5N1 virus has a very complex genetic structure that changes constantly. As the virus comes in contact with ver
Firstly, the H5N1 virus has a very complex genetic structure that changes constantly. As the virus comes in contact with ver
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
y different organisms it is able to gain varied information, thus the new strains will make almost impossible the development of a
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
vaccine. Even more, the human body does not have the capacity to create antibodies for every branch of the virus. With very little i
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
mmunity it is almost certain people won't win the battle against this invisible and lethal enemy.
Furthermore, not only is this vir
Furthermore, not only is this vir
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
us replicating but it is mixing with other viruses, it is acquiring and exchanging genetic material and may eventually be able to cr
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ate such an evolved strain which will devastate continent after continent.
On the other hand, our health -already hanging by a stri
On the other hand, our health -already hanging by a stri
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ng- is also threatened by the other strains of influenza A viruses which could provoke a world wide pandemic.
In the end there is n
In the end there is n
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
o telling whether we will disappear by bird flu or our existence will continue untouched but, until now, chances are not on our side
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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