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Traumatic brain injuries occur in people of all ages and sexes although statistically young men under thirty years of age are more likely to sustain such an

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

injury. The injury may be caused by a fall, a road traffic accident, a deliberately inflicted injury or a physiological problem such as a hemorrhage. The tri

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

Examples of combination products may in

ky thing with brain injuries is that they do not always manifest immediately. The initial assessment in the emergency treatment room may well miss the fact t

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

at serious trauma has occurred. This is in no way a reflection on the abilities of the medical staff, but simply an observation on the nature of the conditio

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

.

If you or anyone around you has suffered any form of injury to the head they should be monitored for a period of 48 hours. The signs to look for, which ma

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

Combination pro

y suggest a traumatic brain injury, are as follows:

- Headaches. These may take any form manifesting in the temples or all over the head. Sometimes the pain

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

starts in the base of the skull and extends over the cranium. The pain may be constant or intermittent.

- Memory. Has there been any problem with memory? Do

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

s the injured person recall the moment of the injury? Do they recognize friends and family? Another sign of memory problems is if the injured person keeps re

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

eating themselves, forgetting what they have already said.

- Sleep. The injured person may want to sleep more than usual and have noticeably lower energy le

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

vels

- Emotions. A traumatic brain injury may be indicated by a change in emotional state. Anger, irritability or depression may be displayed. There could b

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

an impulsiveness in behavior that is not usual.

Do not be fooled into thinking that there has to be a direct blow to the head for a traumatic brain injury

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

Following aspects would a

o occur. The whiplash movement of the head in a car accident can be enough to cause damage to the brain through bruising and bleeding. This in turn can cause

dd to the challenges in developing combination products:

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

swelling and more trauma. All of this happens without there being any visible sign of injury. In fact, it is this kind of closed skull injury that can have t

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

he most serious consequences as treatment can be delayed and the pressure that builds up within the brain can cause more damage than the original injury.

If

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

a traumatic brain injury is suspected it is essential that medical treatment is sought and this will mean going to hospital and in all probability being admi

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

ted, even if it is only for observation. Hospitals can be frightening places for the injured person and for their family members. The information that is ava

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

Professional from academic institutions, pharmaceutical industries, health care indust

lable tends to be in medical terminology and at a level of technical speak that makes it virtually incomprehensible for the average person. It is important t

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

hat the situation and the possible treatments are explained in ways everyone can understand and appreciate.

If a traumatic brain injury is diagnosed and tre

.

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

ted efficiently, the damage can be limited. There is no doubt that traumatic brain injuries change lives but the effect of this change can be minimized throu

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

Companies that provide selfless information through particip

h seeking the help and support that is widely available not only through the medical services but also local and national traumatic brain injury associations

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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