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Its hard to define the word Humanity or kindness but it has a great meaning. We come across it in our every day to day

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

life. It sometimes happen that we come across a incident and it touches us and remains fresh in our memory lifelong.

K

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

Examples of combination products may in

ndness is present in the Heart. It shows what type of person you are and how you see the world.

I remember one of the

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

stories which i would like to share with you all. Many of us has that burning desire to create history and get our sel

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

known world wide. Many people climb Mount Everest , some climb it just out of passion and rest for recognition. Few ar

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

Combination pro

successful and many die in their journey but they take the risk.

One of my friend also had the desire to climb that m

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

ountain, he joined the mountaineering group. He prepared himself with all the necessary things which was needed during

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

he journey i.e jacket, gloves, Spike shoes, Glasses, Turban, Food, oxygen cylinder and other accessories. The voyage st

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

arted. The temperature was in minus with snow clad mountains all around. They halted at various places then reached som

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

where close to the world's highest peak.

He saw a man fighting with the cold and frost bite all alone in one corner.

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

e was very much moved he went there and saw that he was struggling for life. His life jacket was open and he was suffer

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

Following aspects would a

ing from a disease called mountain sickness which most of the travelers suffer. His crew was ready to move but when he

dd to the challenges in developing combination products:

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

old them about the man, they all went to see him. A decision had to be made whether to leave the man to die in that sno

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

w or move back and seek medical care. It was hard to decide as that person was left all alone by his group because he d

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

dnt want to move forward and his friends were not ready to move back.

The decision was made to carry that man back and

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

seek for medical care. It was a tough decision but they agreed. That man was brought back admitted in Hospital and his

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

Professional from academic institutions, pharmaceutical industries, health care indust

finger tips were removed because of frost bite but he was alive. They now feel proud that they took the right decision

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

nd saved a man's life and prevented at least one person from dying on the ranges of the world's famous peak.

We also c

.

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

ome around small situations in our day to day life where we don't care to look into the matter but we can do a lot. I r

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

Companies that provide selfless information through particip

member one good saying of Sally Koch- Great opportunities to help others seldom come, but small ones surround us daily

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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