Advice Pool - Health and Fitness

An estimated 2 million Americans suffer from bipolar disease. Unfortunately, many of them make the walk alone, with few others understanding this condition

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

and its impacts on a person's life.

The reality is many people mistakenly believe those suffering from bipolar disease have control over their behavior. 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

y blame the mood swings on other things and expect for a person to have the ability to "snap out of it" or "get it together."

Sadly, with a misdiagnosis ra

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

te that is extremely high and a biological root for the condition, getting bipolar disease under wraps isn't as easy as many would like to think. There are

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

ome basic things about bipolar disease anyone with a friend, loved one or co-worker should know. These include:

* A person is not in control. When this dis

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

Combination pro

ase goes without treatment, the person suffering from it really does not have control of the mood swings or the symptoms that might arise from them.

* It i

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

s not totally psychological. Counseling will not cure this disease. In fact, bipolar symptoms are tied to a chemical imbalance in the brain. This means ther

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

is a biological root, although not understood, that leads to the periods of ups and downs.

* This condition presents in swings. The key to spotting bipola

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

r disorder over clinical depression lies in the fact that very abrupt and dramatic mood swings are present. Those suffering from the disorder will present w

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

th both manic and depressive symptoms at times. It's even possible they will behave quite normally, or middle of the road, at others.

* There is no known c

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

re. It is currently impossible to "fix" the chemical imbalance in the brain and end the possibility for symptoms all together.

* It is treatable. Those who

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

Following aspects would a

suffer from this condition and obtain a correct diagnosis can, in fact, lead very normal lives. With the correct medications, the mood swings can be brough

dd to the challenges in developing combination products:

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

into check or eliminated entirely.

* People who suffer from this condition are not "crazy." While they may act off at times, their actions have a biologic

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

al, not psychological root.

* The condition's potential side effects can be serious. In and of itself the condition is not fatal, but the various mood swin

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

s can have very grave results. Those in a manic phase, for example, might do something completely out of character and take risks that can lead to accidents

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

injury and even death. In the depressive phase, some people take their own lives.

* It's an easy condition to get under control. This is right and wrong.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Once the correct diagnosis has been made, it is possible to bring the symptoms into complete check through maintenance medications. Unfortunately, the misdi

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

gnosis rate falls in around 70 percent, so completely getting bipolar disease under control can be a very tricky proposition indeed. It is important that th

.

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

e mood swings be documented and brought up to a doctor. Persistence is often key in having the right diagnosis made.

Living with bipolar disease isn't easy

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

Companies that provide selfless information through particip

Many of those who suffer do so alone. When friends, family and even co-workers take the time to understand it better, they are in a better position to help

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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