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Do you have a family member or friend who has committed suicide? Do you know somebody that succeeded in taking ther

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

e own life? Do you feel lost and confused? If the answer is yes to any of these questions, read on.

There is a new

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

Examples of combination products may in

television program on this season called, "Ghost Whisperer." I happen to love ghost programs so I have watched it

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

on occasion.

There was a program on recently about this troubled young man who was in love with a woman. The woman

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

he was in love with was moving out of the state to start a wonderful new job. He was not part of her future.

Whil

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

Combination pro

e this troubled young man was happy for her positive career move, he could not visualize his life without her.

Tha

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

t same evening this man decided to jump off a bridge and end his life. He came back to the, "Ghost Whisper" two yea

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

s later. He was a troubled young man alive but now he was even more troubled a ghost.

The, "Ghost Whisperer" is a

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

wonderful young actress who sees and speaks to ghosts. She helps the ghosts settle there past problems with their f

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

amilies. The families and the ghost have closure. The ghost moves on and the family is happier that they had heard

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

from their deceased family member. Both the ghost and family members are now at peace.

Not all the episodes are pe

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

Following aspects would a

ople becoming ghost from suicide. Some of stories are about people becoming deceased through disease and accidents.

dd to the challenges in developing combination products:

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

In this particular episode the ghost wanted the Ghost Whisper to help him tie up loose ends with his past love so

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

he could move on to the next level.

But the most amazing part of this story is what this young ghost said next.

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

I am sorry I jumped off the bridge and killed myself. I wish I could undo this and be alive again.”

Ladies and gen

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

tlemen what do you think about that statement coming directly from a ghost. I think it is a positive and powerful

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

Professional from academic institutions, pharmaceutical industries, health care indust

statement. It does not matter whether you believe in ghosts or not this is a powerful statement.

Today with teenag

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

e suicides on the rise maybe this statement "I am sorry I jumped off the bridge and killed myself. I wish I could u

.

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

ndo this and be alive today," can stop the teenager in mid stride and think before they leap.

I hope you enjoyed m

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

Companies that provide selfless information through particip

y article. Please feel free to read my other articles. I would love to hear from you.

Copyright 2006 Linda Meckle

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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