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Advice Pool - Pandemic Flu – Why Do the Good Die Young?
The recent medical publications on the reasons why Pandemic Flu is and has been so deadly are key information not only for sci
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
entists and physicians, but for the general public as well. May people rely on their belief that they are NOT at risk when Pan
; 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
demic Flu strikes because they are young and healthy. It is this youth and vigor that actually places them at greater risk tha
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
a small child, a kindly grandfather or even a patient with HIV disease.
The immune response we all rely on to help us fight
The immune response we all rely on to help us fight
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
off and recover from the usual yearly flu is the precise mechanism that Pandemic Flu targets. Unlike other diseases that inact
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
vate portions of the immune response, Pandemic Flu activates key portions of the immune response that result in massive inflam
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
mation and destruction in the lungs and other key organs. This “storm” of immunity is most prominent in those with the stronge
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
t immune system. In 2007, the group with the strongest immune system consists of those age 18 to 40 years old.
How big a diff
How big a diff
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
erence will this make? Check the numbers:
Regardless of age, when Pandemic Flu strikes, 1 in 3 people will fall ill.
Of this
Regardless of age, when Pandemic Flu strikes, 1 in 3 people will fall ill.
Of this
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
33%, hospitalization will be required by 79% of those age 18 to 40 while only 54% of those <18 or >40 years old.
Of those hos
Of those hos
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
pitalized, severe lung injury will occur in 80% of those age 18 to 40 while only 50% of those <18 or >40 years old.
Of those
Of those
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
with severe lung injury, 79% of those age 18 to 40 will die while only 50% of those <18 or >40 years old will die.
What does
What does
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
hat mean when totaled up?
26% of all people age 18 to 40 will be hospitalized (compared to 15% of those <18 or >40)
21% of a
26% of all people age 18 to 40 will be hospitalized (compared to 15% of those <18 or >40)
21% of a
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
ll people age 18 to 40 will suffer severe lung injury (compared to 8% of those <18 or >40)
17% of all people age 18 to 40 wil
17% of all people age 18 to 40 wil
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
die (compared to 4% of those <18 or >40)
Admittedly these are the worst case numbers, but they are based on a combination of
Admittedly these are the worst case numbers, but they are based on a combination of
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
the written accounts of the 1918 Pandemic and the current H5:N1 Avian Flu Outbreak.
So what can we do? Ask a kindergartner!
So what can we do? Ask a kindergartner!
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
1. Wash your hands
2. Don’t share drinks and eating utensils
3. Cover your mouth with your elbow when you yawn, sneeze or co
2. Don’t share drinks and eating utensils
3. Cover your mouth with your elbow when you yawn, sneeze or co
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ugh
4. Don’t sit too close to others (6 foot separations helped stop SARS in Toronto)
5. If you are sick, stay home. Call y
4. Don’t sit too close to others (6 foot separations helped stop SARS in Toronto)
5. If you are sick, stay home. Call y
.
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
u doctor, don’t go to the hospital that is where the sickest people will be. In other words, if you want to catch Pandemic Fl
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
u, hang out in the ER Lobby.
With these simple techniques, you and your family can keep yourself safe when the Pandemic comes
With these simple techniques, you and your family can keep yourself safe when the Pandemic comes
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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