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Depression is not the same as having the blues, nor is it feeling down in the dumps. This clinical condition is much more se

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

rious than a passing mood or a fleeting feeling. It’s one that can hang on for weeks or more at a time, bringing down the pe

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

Examples of combination products may in

rson who suffers and even those around them. It is a very serious condition that can have grave consequences in severe cases

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

With some 16 percent of the total population believed to suffer from depression at some point in their lives, this is not

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

a condition to overlook either. In fact, the World Health Organization anticipates depression will be the second leading cau

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

Combination pro

e of disability in North America alone by 2020. With this in mind, it’s easy to see depression is a real problem.

So what 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 depression, and why should it be taken seriously?

Depression is a serious clinical condition that affects the body and mi

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

nd in a number of ways. Those who suffer often say they feel as if despair has taken over their lives. A veil of darkness th

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

t’s so thick, it’s hard to see through it at anything else, kind of encases them.

The symptoms of depression are many. They

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

include such things as a loss of energy and ability to concentrate. Irritability, sadness, a feeling of hopelessness and ev

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

n thoughts of suicide can go along with the condition. Some people who have the condition will, sadly, act on the thoughts o

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

Following aspects would a

f suicide, never realizing help is available – even for them.

The difference between “feeling blue” and depression is marke

dd to the challenges in developing combination products:

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

d. In depression, a person will feel symptoms for more than two weeks at a time and they might even notice interference with

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

daily life rather rapidly. Feeling anything other than the dark thoughts of depression can be incredibly difficult.

There a

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

re a few basic facts about depression anyone suffering should know. These include such things as the fact those who suffer c

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

n battle their way out, but they might see the condition arise again. Medical/psychological helps is available for depressio

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

Professional from academic institutions, pharmaceutical industries, health care indust

n and it can be very beneficial. Unfortunately, many who are dealing with this condition do not seek help and suffer alone i

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

nstead.

Depression is a very treatable condition, but it can be hard for a person to be willing to seek help. The fact is t

.

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

is condition is one that doesn't single out a person, many people face the grip of depression at some point in their lives.

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

Companies that provide selfless information through particip

Seeking help for depression isn't a sign of weakness, it’s a sign of strength and a step in the right direction for recovery

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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