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It is estimated we humans make an average 2000 decisions per day. Everything from what we will wear,what we eat,which weather rep

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

ort we watch. Incredibly all seem to be consistent with a pattern or habit we have developed. The average person will live about

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

Examples of combination products may in

2 years,depending on gender. This translates to 26,280 days of life if we reach 72 years. Based on the 2000 decisions a day conc

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

pt we will make 52,560,000 decisions in a lifetime. If you are indecisive deduct some.

Most of these decisions of course will be

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

trivial,habitual,uncomplicated and uneventful.

How many of those and the thought we put into them will be our life story?

Sadly

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

Combination pro

many of us allow other people and circumstances to write our epic journey on this planet.Many of us barter our chance at freedom

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

nd independence for a sense of security.Society as a whole is conditioned to accept submission to the current mind set as the tru

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

path to happiness and fulfillment.

Maybe we are just overwhelmed with the enormity of the decisions we must provide. Possibly t

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

is is the reason we have for turning our decision making over to those prepared to do it for us.

What a burden we escape. Now we

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

do not have to figure out when to work,somebody else will do that. Why bother to contemplate which activity to do,someone else is

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

doing that for us. They even have a program implemented to notify us when we are hungry,when we need a break,and when we have com

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

Following aspects would a

pleted our activities they have provided for us.

I imagine we have shaved at least several million decisions from the process. W

dd to the challenges in developing combination products:

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

at progress we have made!

I have heard individuals at the ending of their time here say, "If only I had taken that opportunity w

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

en...., "I did not realize it would go by so fast." . Truly these are not the words of satisfaction, but statements of regret.

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

fter analysing this concept of decision making I have come to this conclusion.

When everyone is thinking the same thought ,only

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

ne person is doing the thinking.

If people are unable to discipline themselves,others will do it for them.

Security is in our a

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

Professional from academic institutions, pharmaceutical industries, health care indust

ility to perform.If we cannot or do not perform we will be replaced by somebody who can.

Happiness is the progressive realizatio

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

of our personal goals and dreams.

Money in the bank and the choices it provides,does not equate to our level of joy and persona

.

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

fulfilment.

People need to be in control of their decision making to be truly free. Ultimately that places the responsibility o

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

Companies that provide selfless information through particip

our life' s result in our own lap.

I suppose you must decide which path is right for you.I have enough decisions to make myself

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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