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Many people believe it will never happen, that a Bird Flu Pandemi

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

c killing millions of people racing through the country cannot oc

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ur. Yet in recent history; the last 400 years there have countles

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

s incidents where pandemics have wiped out millions of people and

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

very rapidly too. The United States has the best chance of many p

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ople surviving such an incredible pandemic, but we are not withou

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

t risk.

Many of the customs in the United States, such as shakin

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

hands, kissing, etc can be problematic for spreading the Bird Fl

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

u Virus is a notable human strain develops and it very well could

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

too. The 1918 Influenza Pandemic killed millions in Europe and al

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

o many in the United States. Some say a viral strain of the Bird

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

Flu could easily kill millions now in the present period due to t

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

e closeness of human populations, air-travel and the fact that ma

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ny cities have very dense populations. Consider some of the major

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

cities in the World Today.

A Bird Flu Pandemic could travel to 5

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

continents in a few days and end up everywhere in the World in a

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

few more. The CDC is extremely worried and in fact the United Sta

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

es Government has already developed a worstcase scenario plan to

.

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

deal with such an unfortunate potential eventuality. Is your fami

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

y safe? Do you have a plan to protect them? Consider this in 2006

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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Useful Advices - Is Your Company Ready for The Bird Flue Pandemic?

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