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I reside in a vowel shaped house. I hate to be inside. But I can’t come out when I wish. Once I come out, I cannot go in. If I da

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

re to come out, I will be ruined. If I don’t, you will be in deep sorrow. Who am I? I am someone delicate who is wiped away as I

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

Examples of combination products may in

come out. I am just a transparent pearly ‘Tear drop.’

Some people hate me while others like me. My existence is due to the pres

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

nce of problems, sorrow or extreme love. When you are in deep trouble, invite me. Let me jump out of your beautiful eyes and fall

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

apart. Only when I come out, will you be in happiness. You often keep me inside of your eyes as if I am your precious secret hid

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

Combination pro

den treasure. But I like to explore the world, enjoy the outer beauty. Of course, I am very precious for your loved ones. When I

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

ay on your cheeks, your beloved wastes no more minute to grant all your wishes. Am I not precious to him and indirectly to you?

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

I am precious when I sit inside the little eyes of the children too. It is then their parents fulfil their greatest wishes. Some

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

of them prefer my company to express their needs of hunger, thirst and their other little needs.

Tear away your sorrows which ha

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

e resided on your heart for ever by letting me out. Let me hug the walls of your eyes to relieve you from your sorrow. I come as

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

a result of your pain but when I come out, the heaviness of your heart is relieved. My appearance is only to see the smile dance

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

Following aspects would a

on your lips. As I come out, I wash away the dirt in your eyes as well as your problems residing in your heart forever.

Are you

dd to the challenges in developing combination products:

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

ware I am treated very precious as well as low? Let me out only when needed. If I appear in petty circumstances, I will be treate

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

d low as well as you. So be careful when you want me. When I rarely appear on your cheeks, people admire you for your mental stre

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

ngth and balance. If I am seen often, they call you timid.

Problems are your eternal shadow no matter what season it is. You are

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

a boat sinking and floating like waves of sorrow and happiness in the ocean of Life. You are a human being capable of choosing yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ur own path to reach your destiny. Walk on failure to achieve success. Being optimistic in pessimistic times is true optimism. Gr

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

eat failure is better than mere success because the former involves hard lessons which smoothen your path of your future life. Do

.

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

’t strive about my existence or appearance. Smile attracts smile, for it is contagious. So laugh and leave anger. Love and live l

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

Companies that provide selfless information through particip

onger without me.

“Tears make your happiness come and go where as Laughter makes your happiness come and grow.” - Sharmila Sank

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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It has often been said that quality of products and service is the key to business success and for the most part it is indeed fact. Now then many marketing consultants say that; Nice People is the icing on the cake.

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