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Almost 2.7 million Americans have been afflicted with epilepsy. That means 9 out of every 1000 Americans have the disorder.

Although statistics show that more men are afflicted with epilepsy than women, e

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

verybody is susceptible to having epilepsy. It can happen to any body, of any race and at any age. However, people with certain conditions are at greater risk of acquiring epilepsy.

It can be remembered th

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

Examples of combination products may in

at in the twentieth century, some states in America banned people from marrying for fear of passing on the disease to their children. Some even had to go through sterilization to prevent reproduction. This

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

s due to the widespread belief that epilepsy is 100 per cent hereditary. This practice only stopped with the passage of the Disabilities Act.

And yet, although epilepsy is not necessarily inherited, the fa

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

mily members of a person with epilepsy have a higher risk of developing the disease. The siblings of a child with epilepsy, for example, are more likely to develop the disorder. This is not because epilepsy

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

Combination pro

is contagious but is due to the likelihood of a genetic tendency to develop epilepsy. More so, epilepsy is more likely to occur in siblings of the child who suffers from generalized seizures. In fact about

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

4 to 10 per cent of the other children in the family will develop epilepsy. But this still depends on the type of epilepsy and the number of afflicted family members.

In addition, children of parents with

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

epilepsy are also at a greater risk of developing epilepsy, pegged at 5 per cent. The risk for children whose father has epilepsy is slightly higher than children whose mother has the disorder. However, the

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

risk is even higher if both parents have epilepsy. Although genetics is a risk factor in developing epilepsy, the risk is relatively low and should not be a cause of great alarm. In addition, even if the ch

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

ildren develop the disorder, most of them will definitely outgrow epilepsy by the time they become adults. The advances in modern medicine make it possible to control seizures.

Age is another factor in the

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

development of epilepsy. Although the disorder can strike at any age, children and teenagers are more susceptible. In fact, almost 50 per cent of all cases of epilepsy occur before ten years of age while 30

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

Following aspects would a

per cent of the cases are those with ages 10-19. The remaining 13 per cent are people aged 20-29 while ten per cent are those aged 30 and above. Although children have a higher risk of developing the disor

dd to the challenges in developing combination products:

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

der, they tend to experience a reduction in frequency and intensity of the seizures as they grow into adulthood. Some even outgrew the disorder completely.

In addition to the genetic and age factors, peopl

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

with certain conditions pose a greater risk of developing epilepsy. Studies confirm that up to 5 per cent of the world’s total population may experience a single seizure at one point in their lives. Half o

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

f seizure cases without a clear cause are more likely to suffer a second seizure within a span of six months. Having two of such seizures, there is 80 per cent chance that it is epilepsy. Although the exact

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

cause of epilepsy cannot be pinpointed, there are known factors that double the chances of developing epilepsy. Such risk factors include the following:

Babies who experience seizures during their first mo

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

Professional from academic institutions, pharmaceutical industries, health care indust

nth

Babies with inborn abnormal brain structures

Babies who are too small for their gestational age

Brain hemorrhage or internal bleeding

Abnormal or unstable blood vessels in the brain

Brain injuries

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

Lack of oxygen to the brain

Cerebral Palsy

Brain infections such as abscess, encephalitis and meningitis

Brain tumors

Mental illness

Stroke due to the blockage of arteries

Early post-traumatic seizur

.

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

s

Degenerative diseases like Alzheimer’s disease

Drug abuse

Fever-related seizures

Even though finding out the cause of epilepsy is nearly impossible, the best thing one can do is to avoid the so-called

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

Companies that provide selfless information through particip

seizure triggers such as intoxication, nutritional deficiencies, over-the-counter drugs that decrease the effectiveness of seizure medicines, severe stress, lack of sleep, drug abuse and missed medications

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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