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Our soldiers have the most advanced protective gear and medical treatment they have ever had during a time of war. This means that more soldiers than ever are surviving

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

combat. It also means that those who are injured can survive with more serious injuries than ever before. The combination of high survival rates and the increased use

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

Examples of combination products may in

f explosives, means that many soldiers are coming home with amputations and head injuries, making traumatic brain injury (TBI) the signature wound of the war in Iraq.

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

n past wars, TBI made up a much smaller percentage of injuries, and most soldiers who incurred a brain injury did not survive. Today, somewhere between 22% and one-thir

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

of soldiers are coming home from the war with TBI and surviving. Because many of these injuries are caused by IED’s (improvised explosive devices), they are concussion

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

Combination pro

injuries with no visible head wound. Many soldiers with TBI are not aware that they have a brain injury.

Brain injury and post traumatic stress disorder
Post trau

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

atic stress disorder (PTSD) and brain injuries can have the same symptoms. Both can create psychological, emotional, social, and cognitive difficulties, making adjustme

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 to civilian life after combat extremely difficult. Additionally, TBI can cause physical disabilities alone or in combination with other wounds. Physical and emotional

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

problems caused by TBI can appear to be a combination of PTSD and direct physical injury, with the brain injury going unrecognized and untreated.

Brain injury and epil

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

psy
Epilepsy is very common in brain injury victims. Over half of all people with TBI develop epilepsy within one year of being injured. Currently, epilepsy affect

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

about one to two percent of the population. With the high incidence of TBI in veterans, experts worry that we could see a surge in epilepsy rates in coming years.

Ear

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

Following aspects would a

ly warning signs of epilepsy can also be mistaken for symptoms of PTSD. Warning signs of epilepsy include:
· Lapses in memory
· Strange sensory auras
· C

dd to the challenges in developing combination products:

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

anges in behavior
· Attention problems
· Depression

People who do not know that they have epilepsy can have seizures without ever knowing it. Because they ha

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

e no memory of the seizure, it often takes someone else witnessing the event for them to find out. The only other real clue is if the epilepsy victim notices signs that

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

they have experienced a blackout. Many people are frightened by the implications of having blackouts and do not want to face the possibility or discuss it with others.

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

Getting the right care
The brain is still a medical mystery and treating brain injuries can be difficult and unpredictable. Proper and effective treatment means se

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing specialists. The best chance of recovery means getting care from doctors who have advanced knowledge in the latest TBI treatments.

The VA claims to have the knowle

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

ge and experience to provide adequate care to veterans with TBI. They are not prepared to handle the large number of soldiers who are coming home with brain injuries. M

.

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

ny loved ones feel that “adequate” is not good enough. When the VA fails to produce improvement, many soldiers seek private care, and experience a rapid recovery. The V

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

Companies that provide selfless information through particip

discourages seeking private care, but some soldiers are allowed to seek care from private hospitals and still have their medical bills paid by their veteran’s benefits

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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Use private label marketing to boost your business profits. Examples from within the beverage / tea industry...

Everything is so easily accessible nowadays with the technology of computers. It makes no difference if it is banking, sending letters or ordering food, we can do everything online. No one even imagined that ordering groceries on your computer and have them delivered right on your doorstep would be possible twenty years ago.

Being injured on the job can be both a scary and painful time, and there are many employees who are not sure how they should respond and what they should do if they are injured on the job

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