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Brain injuries can occur as a result of many different incidents, including: § Open Head Injuries –

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

Occur when the force of an object pierces the skull and damages the brain. Open head injuries can

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

Examples of combination products may in

be caused bullets, or any other object that penetrates the skull.

§ Closed Head Injuries – A closed

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

head injury occurs when an outside force impacts the head, causing the brain to shift and collide wi

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

th the inside of the skull. Falls and motor vehicle accidents most often cause closed head injuries

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

Combination pro

§ Chemical Brain Injuries – If certain chemicals or poisons enter the body, they can cause serious

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

damage to brain cells, causing permanent damage to the brain. The most common chemicals and toxins

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

that cause this traumatic brain injury are insecticides, carbon monoxide, and lead poisoning.

§ In

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

ections – If an infection is allowed to grow within the body, it can affect the brain, causing the b

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

rain to swell and become damaged from pressing against the inside of the skull.

§ Hypoxia – If the

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

ody is deprived of oxygen for too long, it can cause serious damage to the brain because it is not r

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

Following aspects would a

eceiving the oxygen it needs to stay alive.

§ Stroke – If there is a blockage in the blood flowing

dd to the challenges in developing combination products:

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

to or from the brain, it can cause irreparable damage to brain cells, causing long lasting effects a

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

d disabilities.

Traumatic brain injuries are often misdiagnosed, or undiagnosed. Many times, the o

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

nly people aware of the effects of the traumatic brain injury are the victim or their loved ones, wh

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

notice subtle changes or differences. Even “mild brain injuries” can have numerous, long lasting e

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

Professional from academic institutions, pharmaceutical industries, health care indust

ffects on the victim and their family. Common traumatic brain injury symptoms include:

§ Headaches

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

§ Memory Loss
§ Seizures
§ Fatigue
§ Depression
§ Dizziness
§ Poor Co

.

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

centration/Attention
§ Confusion
§ Impulsiveness
§ Speech Problems
§ Problems C

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

Companies that provide selfless information through particip

omprehending Things
§ Chronic Pain
§ Difficulty Controlling Bowels
§ Irritability

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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