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To some people, nothing could be more exciting than winning a hand of Texas hold-em on

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

the river. The adrenaline rush, the thrill of victory…all adds up to a great time. Th

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

Examples of combination products may in

anks to national television coverage of poker tournaments on nearly every channel, gamb

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

ling has made its way into the mainstream. There’s a good chance that you’ve played Te

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

xas hold-em at some point. You might even play a few times per week. There is nothing

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

Combination pro

wrong with gambling, but how do you know if you’re addicted?

Gambling addiction is a

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

terrible problem in our world today. It has always been around but at no time has it c

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

ontrolled as many people as it does today. It tears lives and families apart. There a

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

re several signs that point to a gambling addiction.

How seriously do you take gamblin

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

g? Gambling is a game and it should always remain so. If you find yourself getting ex

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

tremely angry after a hand, you might be addicted. Are you betting your discretionary

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

Following aspects would a

income or much more? There is nothing wrong with playing a few hands of poker with the

dd to the challenges in developing combination products:

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

guys as long as you don’t play for pink slips. Some people bet their life savings and

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

their kid’s college funds. If this is you, please stop! Only bet what you can afford

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

. The adrenaline rush that you get after a win is nothing compared to what it feels li

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

ke to lose all your money. Many people have left Las Vegas with only the shirt on thei

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

Professional from academic institutions, pharmaceutical industries, health care indust

r backs. Don’t let that happen to you.

If you think that you might have a gambling ad

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

diction, there is help available. Don’t be too proud. Many people battle this problem

.

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

every year. You can beat it with the help of a support group or even counseling. The

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

Companies that provide selfless information through particip

important part is that you admit you have a problem. Keep gambling what it is…a game.

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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Advice You - Are You Addicted To Gambling?

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