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Once lived a great king who was getting old and wanted to retire. One day he announced that all his personal wealth would be distributed to the public. However one would have to earn

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

his share as the king did not want the wealth to go to unworthy.

His wealth would be in the seven stories of his palace. One might take whatever one wished, he announced. The word

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

Examples of combination products may in

pread fast and people gathered. No one wanted to miss this opportunity of getting rich.

The entrance was opened and people eagerly rushed in. Presented to them were common items of

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

ottery, glass and earth. They checked every place. Nothing else was there. People got disappointed. This was not what they had expected. Many left cursing.

Others decided to try sec

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

nd floor. As they moved there they found things which were costlier but nothing which could be called wealth. Many left again. It was wastage of time after all. The king either had g

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

Combination pro

ne mad or played a bad joke

Rest of them pushed themselves to the next level through a passage that was narrower and steeper. Here displayed were some coins of lesser value. Discour

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

ged quite a number left again. I was clear now that the king had really played a joke. There was no wealth to be found.

Few who were encouraged enough resolved to go to further. Th

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

ey had to walk a path harder than previous. Those who could not tread returned. Only a handful reached fourth storey and were rewarded with silver coins.

Joyfully many stuffed and l

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

ft. Thank God! The day was not wasted on some misadventure. They had come from far. They were tired now. They did not want to go further. They had work at their homes too.

However,

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

ten people decided to go ahead. It was a very difficult journey. The was almost vertical and very rough. Only four could reach next level. Others left, not being able to continue. Th

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

se who reached found gold coins in abundance. Two decided to end here and left with gold happily.

Two went further on a path that was almost impossible to walk. They did manage to r

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

Following aspects would a

ach sixth floor. It was a hall full of diamonds of finest quality.

Pleased with this one started filling his bags whereas other went into deep thoughts.

“What happened? You don’t w

dd to the challenges in developing combination products:

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

nt this” asked the one who was filling.

“I wonder what could be next!”

“What else do you want? This is more than enough for seven lifetimes. Moreover I can’t see any doorway” Other

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

man was astonished.

“But there is one floor left” said the man who was determined and began his search.

“You have gone mad” said other and left with diamonds.

There was actually n

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

o door. The man searched every corner but none was to be found. That was until he saw roof and a rope hanging too small to reach. He jumped and failed.He tried repeatedly without suc

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

ess till he could not jump.

There has to be some way, he thought as he lay exhausted. There must be some way.

It was then an idea struck him. He made a heap of diamonds to reach an

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

Professional from academic institutions, pharmaceutical industries, health care indust

pulled the rope. A doorway appeared in one of the walls. Beyond that was a beautiful ladder. As he climbed a hand pulled him to seventh floor.

The king himself stood there “Welcome

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

O worthy one! I can retire in peace now”

The man was appointed as king next day.

Nature too offers us a fortune of wealth that we can earn. Everybody wishes to be rich but not all

.

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

re ready to fully walk the path that leads to. Most of us who start get discouraged by initial unsuccessful attempts and stop. Others remain satisfied with the nickels they are offer

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

Companies that provide selfless information through particip

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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This article includes a combination of ten questions and suggestions that will provide the tools necessary to get a medical insurance policy that will best work for you and your family.

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