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Depression is an overused word to describe how someone may be feeling. It is often used to de

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

scribe moments of sadness or disappointment, where those descriptions may be more on target an

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

Examples of combination products may in

more clearly define a course of action.

Clinical depression is more than feeling bad for a f

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

ew days; it is a common, yet serious, illness that affects almost 10% of Americans each year.

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

nfortunately, only one-third of sufferers seek treatment even though getting assistance can he

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

Combination pro

p 80 percent of all people who are affected. Although depression is a real medical illness, ma

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

ny people still mistakenly believe it is a personal weakness. Events such as the death of a lo

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

ed one, divorce, financial strains, moving to a new location or significant loss can contribut

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

to the onset of clinical depression. It is not only negative events that can trigger depressi

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

on. It is often the sum of many events, even good ones like getting married or finding a new j

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

b.

If you have experience 5 or more of the symptoms below for more than 2 to 3 weeks it is ti

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

Following aspects would a

e to talk to your doctor and/or a counselor.

• Do you feel sad or irritable?
• Have

dd to the challenges in developing combination products:

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

you lost interest in activities once enjoyed?
• Have you experienced changes in weight

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

r appetite?
• Have you experienced changes in sleeping pattern?
• Do you have feeli

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

gs of guilt?
• Are you unable to concentrate, remember things, or make decisions?
•

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

Have you experienced fatigue or loss of energy?
• Have you experienced restlessness or d

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

Professional from academic institutions, pharmaceutical industries, health care indust

creased activity noticed by others?
• Do you feel hopeless, or worthless?
• Have yo

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

had thoughts of suicide or death?

Clinical depression is one of the most readily treatab

.

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

le illnesses, and getting treatment can truly save lives. The most common ways to treat depres

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

Companies that provide selfless information through particip

ion are with antidepressant medication, psychotherapy (talk therapy), or a combination of both

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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