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Bird flu, also known as avian influenza is a disease which affects the birds, especially the poultry, in different extents. The bird flu is produc

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

ed by subtypes of influenza A virus and it sheds in the wild birds which transmit the virus to the poultry. The H5N1 subtype is considered to be t

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

Examples of combination products may in

e most pathogenic virus from all the subtypes of influenza A virus.

Chicken, ducks and turkeys get infected if they get in contact with discharge

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

from infected birds, infected water, and infected vehicles. The eggs can also contaminate the incubator if they are from infected hens.

The bird

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

s which survive the infection can spread the virus for another period of at least 10 days through secretions, discharges and feathers.

The virus

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

Combination pro

an easily spread in the area if a contaminated bird is left to roam freely; if it drinks water from the place other birds drink, this way contamin

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

ting the water. Cars can spread the virus also from one place to another if they are not disinfected properly. Shoes, cages and clothing are also

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

a way of spreading the virus.

Humans can get infected if they get into close contact with ill birds. People who transport poultry, who feed them

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

nd clean the place the birds live in, are exposed to the virus if the birds are infected. Eating cooked chicken meal is not dangerous as the virus

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

gets inactivated at heat.

Until now human to human transmission was not encountered.

The governments are concerned that the virus could mutate a

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

d achieve the ability of transmitting itself from one person to another. This could lead to a global pandemic and millions of people might die. Al

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

Following aspects would a

so, if this problem is not solved quickly the poultry industry will suffer and the economy of the country will drop.

In chicken the bird flu give

dd to the challenges in developing combination products:

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

these symptoms: diarrhea, muscle weakness, breathing problems, sudden deaths, facial swelling, and a decline in the egg production.

In humans th

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

symptoms of bird flu are: fever, muscle pain, sore throat and then cough, breathing problems and multi-organ failure in the last stage of the dis

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

ease.

As there are so many diseases which manifest very much alike with bird flu the doctors must be very careful when diagnosing bird flu. If th

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

patient got into close contact with a sick bird, or handles bird cages, laboratory tests will be done to see exactly if there is a bird flu infec

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

Professional from academic institutions, pharmaceutical industries, health care indust

ion.

There has not been yet discovered an effective vaccine against bird flu virus. The only thing humans can do is take a shot for a human influ

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

enza virus to prevent the recombination between the bird flu virus and human flu virus which could form a more threatening virus.

In order to pre

.

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

ent bird flu people must avoid getting into close contact with birds or their discharges; must not buy any living bird illegally as they are not c

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

Companies that provide selfless information through particip

ntrolled by the veterinaries, must report any suspect death of a bird to the authorities, and must disinfect properly after handling bird products

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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