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What are the long-term consequences of traumatic brain injury? Individuals with brain injury oft

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

en experience problems with both vision and hearing loss. Carolyn Rocchio of the Brain Injury As

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

Examples of combination products may in

ociation says the following about traumatic brain injury:

“Hearing problems can occur for a numb

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

r of reasons, both mechanical and neurologic, particularly when the inner ear and/or temporal lob

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 have been damaged. All patients should have an otoscopic examination and hearing screening foll

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

Combination pro

wed by behavioral testing. External bleeding in the ear canal, middle ear damage, cochlear injury

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

and/or temporal lobe lesions can cause auditory dysfunction.” (Rocchio, 1998)

According to the

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

Brain Injury Association website, traumatic brain injury (TBI) is defined as: “An insult to the

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

rain, not of degenerative or congenital nature caused by an external physical force that may prod

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

ce a diminished or altered state of consciousness, which results in an impairment of cognitive ab

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

lities or physical functioning. It can also result in the disturbance of behavioral or emotional

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

Following aspects would a

unctioning. Acquired brain injury (ABI) is defined as “Injury to the brain which is not her

dd to the challenges in developing combination products:

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

ditary, congenital or degenerative that has occurred after birth.”

According to The Centers for

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

isease Control and Prevention, at least 5.3 million Americans currently have a long-term or lifel

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

ng need for help to perform activities of daily living because of traumatic brain injury.

An est

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

mated 40% of those hospitalized with a TBI have at least one unmet need for services one year aft

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

Professional from academic institutions, pharmaceutical industries, health care indust

r their injury. Most frequently:

* Improving memory and problem solving;

* Managing stress and

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

motional upsets;

* Controlling one's temper; and

* Improving one's job skills.

TBI can cause a

.

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

wide range of changes affecting thinking, sensation, language, and/or emotions. It can cause epil

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

Companies that provide selfless information through particip

psy and increase the risk for Alzheimer's disease, Parkinson's disease, and other brain disorders

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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