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During the course of our lives, we all experience ups and downs. Some days we feel happy and care-free, while on other days we just can't shake the blues

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

. While we may find these mood changes bothersome, they do not disrupt our lives.

In some people, more specifically those diagnosed with Bipolar Disorde

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

Examples of combination products may in

r, mood changes are so drastic and severe that those suffering from the disorder often cannot function in the normal world. Once called Manic Depressive

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

Disorder, the disease responsible for these drastic mood swings is now called Bipolar Disorder.

Those suffering from the disorder will fall into one of

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

four subcategories of the disease. These subgroups include Bipolar I, Bipolar II, Cyclothymic Disorder and Bipolar NOS.

In order for a patient to be cla

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

Combination pro

sified as Bipolar I, they must have experienced at least one or more manic episodes or mixed episodes. During a manic episode patients will experience an

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

extremely elated or euphoric mood. Along with an elated mood, the patients will usually also have increase mental or physical abilities. They also requi

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

re little sleep during these episodes.

That sounds great, right? So what's the problem? While the manic episodes can bring on an elated mood, those suff

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

ering a manic episode may also be suspicious or irritated, have a low attention span or be easily distracted. Worst yet, a deep depression can sometimes

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

follow one of these elated periods.

During these periods of depression, the patient may feel unable to even get out of bed each day. These individuals m

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

y also suffer what is called a mixed episode. This is defined as a period of time when symptoms of mania and clinical depression can occur at the same ti

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

Following aspects would a

me. Bipolar individuals are often most dangerous, sometimes to others but mostly to themselves, during this state as their moods are in constant flux and

dd to the challenges in developing combination products:

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

easily changed.

Of all four subcategories of Bipolar Disorder, more people are diagnosed with Bipolar II. In order to be diagnosed as suffering from Bi

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

polar II, the patient must have suffered at least one hypomanic phase and one depressive phase. A hypomanic phase is similar to a manic phase, but is gen

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

erally not as debilitating or destructive as the manic phase can be.

The third subgroup of Bipolar Disorder is the Cyclothymic Disorder. Bipolars in thi

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

subgroup often show signs of mood cycling from hypomania to depression but those around them usually accept the mood swings as a personality trait inste

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

Professional from academic institutions, pharmaceutical industries, health care indust

ad of a disorder. Also, the periods of depression do not meet all the criteria of a major depressive episode.

The fourth subcategory of this disorder is

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

Bipolar Disorder Not Otherwise Specified (NOS). This subgroup generally contains those who are suffering from some type of Bipolar Disorder, but do not

.

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

fall into any of the above subcategories.

Bipolar Disorder is a disease of variations in mood. It can wreak havoc on the lives of those suffering with i

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

Companies that provide selfless information through particip

t and also those who must try to live and work with these people. There is help for those diagnosed with any form of Bipolar Disorder. Don't give up hope

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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