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Are you a fortunate person to have someone in your life who cares for you? I don't mean care

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

in the sense it is commonly used. But who cares for you like your mother used to when you wer

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

Examples of combination products may in

a child? You are a grown up person now. Does that imply that you don't need anyone to take y

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

ur care? Don't you need someone to ask you if you are Ok? And then to try and make you comfor

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

able? Don't you need someone who knows what you like and then to arrange for it? Don't you ne

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

Combination pro

ed someone who will put balm on your aching legs? Who will smother you with love, when you fe

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

l lonely?

Don't you want someone to just come and sit beside you and talk to you in silence?

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

Don't you need someone who will make you cry, because you want to, but can not because you ar

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

an adult? Don't you feel that you need someone in front of whom you can cry your heart out?

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

And be sure that someone will wipe your tears? Or because you are adult, such things are not

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

one? Even if one feels extreme pain of any kind, one can cry either in churches or all alone

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

Following aspects would a

n a park? We are adults. But there is a child in all of us. We are fighters, but sometimes we

dd to the challenges in developing combination products:

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

lose the battles. We can bear every pain, but sometimes the pain can overcome our capacity. W

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

e all need a person in our life, who can be our mother, even if we are eighty years old. Who

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

an understand that we need care. We wish to be pampered. We want someone to take our face in

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

ap and comfort us . Yes, we can deny all this, but we need someone who cares for us.

All of

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

Professional from academic institutions, pharmaceutical industries, health care indust

s need a person who takes our care. If we are allowed to cry, if we are made to speak about a

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

ll our troubles, if we are pampered to relax us, we will feel heavenly. But unfortunately we

.

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 all adults. These essentials of living are for kids. For adults, it is a corner in their h

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

Companies that provide selfless information through particip

mes or in the office, where they can sit and worry and show to the world that they are adults

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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