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We have all met them: the highly successful businessman, the indispensable boss, the key team member. They are the best at what they do. They are appreciated by everyone. They are

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

making money hand over fist. They have high blood pressure and heart problems. They drive a nice car and live in a nice house. They often have a wonderful family or trophy spouse.

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

Examples of combination products may in

They are at the top of their game and could drop dead at any moment. They are usually well-mannered, sometimes charming. They smile and laugh. But what you see is all that you get:

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

they are not happy. They are trapped. The bars of their cage are made of gold. They have large payments and big mortgages.

Our culture makes it difficult to believe that success

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

an be stressful. We are taught that lack of success is stressful. If only we could make it to the top everything would fall into place. We would be happy and those we love would be

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

Combination pro

secure. our worries would be over. The kingdom would have come.

Type A behavior comes with a price. Most of the time success requires a very large amount of dedication, energy an

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

d focus. Those who get to the top of the mountain say that it is a difficult climb with many sacrifices: sleep deprivation, few pastimes, litte if any leisure and a great deal of f

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

cused intensity.

What is the stress of success all about? Simple: the plan is working but not yet accomplished. The successful person has gotten halfway across the bridge, far eno

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

ugh out so that there is no turning back but not across to the other side. It is the point of do or die.

Often the bind is financial. There is too much debt to afford retirement.

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

There are too many payments to cut back on work but not enough stamina to keep up the pace. The person has been reduced to all work and no play. Their doctor worries about their he

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

lth and usually gets an argument if and when this person actually checks in. The classic scene depicting this situation is the doctor at bedside saying the choice is to cut back or

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

Following aspects would a

have a more serious heart attack.

The busines scene is loaded with people heading for this type of burnout. They are to be found at every level, from the lowest worker on the tot

dd to the challenges in developing combination products:

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

em pole to the top executive and everywhere in between. In big business firms the corporate culture rewards success. In the 20 million small businesses the name of the game is prod

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

uce or perish. And the business side of the professions has physicians, attorneys, accountants,contractors and dozens of other professionals going around the clock. Time has become

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

money.

Stress management begins by recognizing that success brings stress. There truly is stress and that stress needs to be managed. Physical workouts and proper nutrition are pa

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

rt of the program. Other parts of the program need to include time outs, proper amounts of rest and sleep, relaxation and effective venting of tension. In other words, pay attentio

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

Professional from academic institutions, pharmaceutical industries, health care indust

n to being human. Limit setting is probably the greatest challenge of all.

Those successful people who learn to set limits are likely to live long enough to enjoy their success. T

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

ose who do not set realistic limits will also likely succeed. Their obituraries will note that they died at the very pinnacle of their success.

Tragedy in the view of Greek philos

.

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

ophy was suffering that did not need to happen. Some bad things happen in life and cannot be avoided. But other bad things happen because we did not have the wisdom to avoid them.

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

Companies that provide selfless information through particip

Success does not need to be overly stressful. It is possible to have cake and eat it too, but one needs to learn stress management and build into the plan provision for being human

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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