E-Articles - Health and Fitness

There are several things you inherit from your parents the color of your hair and eyes, your skin tone

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

, even your height. You inherit these traits because you have genes and these genes make up your DNA.

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

Examples of combination products may in

Unfortunately, you also inherit predisposition to certain diseases and even mental illness. Researches

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

have recently shown that depression could actually be inherited. It simply means that if someone in y

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

ur family is suffering from clinical depression, then there is a very high probability that you too co

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

Combination pro

uld become depressed.

Years ago, scientists did not really know where depression came from. The envir

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

onment was always identified as the primary suspect as the cause of depression in general, but more re

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

ent studies show a strong evidence that clinical depression such as depressive disorder, manic depress

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

ion and dysthymia is actually caused by chemical imbalances, the predisposition to which is inherited.

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

The results of recent studies show that if you do have a parent, an uncle, a brother or a sister who

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

is suffering or has suffered from clinical depression, you have 1.5 to 3 times more chances of develop

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

Following aspects would a

ing the same condition than someone who does not have such a condition within the family.

Recent rese

dd to the challenges in developing combination products:

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

arches have not really been successful in trying to narrow down the research to specify which gene act

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

ually causes clinical depression. Different studies have yielded different results. It was hypothesize

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

that the gene may be different from one family to other, but this has never been proven to date.

So

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

there is no actual conclusion as to which gene is the culprit that causes clinical depression. But the

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

Professional from academic institutions, pharmaceutical industries, health care indust

re is very little debate about the fact that clinical depression is hereditary. It is nothing to be as

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

amed of in fact, depression is so common that it affects more than 19 million Americans each year. How

.

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

ever, less than half of the people suffering from this mental illness acknowledge it and seek treatmen

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

Companies that provide selfless information through particip

t. If you or someone in your family may be experiencing depression, consult a psychiatrist immediately

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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