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A lover, who claims to love, can never hurt his/her beloved. Love demands

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

that you care utmost for your beloved. You are concerned about their feeli

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

Examples of combination products may in

ngs. You make them as comfortable as possible. You keep them as happy as p

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

ossible. You help them fulfill their dreams. You encourage them during tou

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

h times and you are always there for them. If you don't do this, there wil

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

Combination pro

l be nothing called as love. The definition of love includes the qualities

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

I mentioned.

This does happen. In many relationships it happens all thro

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

ugh the life. Such couples need not worry to know about heaven. Their home

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

is heaven. But in some relationships, if a lover wishes to break away for

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

any reason including feelings of being treated unjust, the results will be

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

harrowing.

Let us look at what will happen. As the lover who wishes to b

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

Following aspects would a

reak away remembers all the investments she/he did for the love, she will

dd to the challenges in developing combination products:

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

eel that all has gone waste. All my sacrifices are in vain. I did so much

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

for many years, and now what is the result? This frustration and anger is

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

directed towards the partner. At that time the lover who is breaking away

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

forgets that worse will happen to one she /he will be leaving. Only selfis

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

Professional from academic institutions, pharmaceutical industries, health care indust

thoughts occupy the mind.

This is the tragedy of such love. The one who

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

is left behind might have made more sacrifices and given a lot more for lo

.

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

ve. He/she gets bewildered at why this break up is happening? It is like a

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

Companies that provide selfless information through particip

sudden earthquake. That is why I asked, that if you love someone why hurt

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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