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Yep…

You read that right!

Now before you lose your mind, let me explain.

You see, generally, people have a tendency to shoot

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

for success or the positive side of things and forget the negative.

It doesn't matter if your goal is business success or a per

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

Examples of combination products may in

sonal life goal.

When people reach their goal, they jump for joy but…when something unexpected or negative happens, they start

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

pointing fingers or become disgusted, upset and pretty much give up.

They say things like, "Yeah maybe this wasn't meant for me

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

."

Or my favorite, "Well I tried and it didn't work out!"

Well the question I always ask is WHY?

Why didn't it work out or wh

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

Combination pro

isn't it meant for you?

Now you might just think from the title of this article that I'm about to tell you that these people 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

re failures and if you feel the same then you're a failure too.

No way!

The fact is that it takes Failure to be a Success.

Ma

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

ybe you should read that again.

It's okay to study failure, YOUR failures and the failures of others and look for the golden nu

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

ggets of knowledge that are built into them.

Success is inherent in failure. So seeking failure and analyzing what happened or

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

reversing the process that lead to that failure you will find the cause of that failure.

All you have to do is look. Keep in

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

ind you must look for it openly and without prejudice.

The truth of the matter is that you now know or understand the truth abo

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

Following aspects would a

ut success and it is Failure.

Failure is a greater asset to most than they care to realize.

Only when you knowingly give up on

dd to the challenges in developing combination products:

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

your dreams or desires do you truly become a real failure.

Failure is the key to finding and building the road to success. The

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

Truth About Success: Forget Success, Be a Failure!

Seek success and learn from failure and you will achieve greatness!

Or bet

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

ter said…

"It is not the critic who counts, not the man who points out how the strong man stumbled, or where the doer of deeds

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

could have done better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and b

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

Professional from academic institutions, pharmaceutical industries, health care indust

ood, who strives valiantly, who errs and comes short again and again, who knows the great enthusiasms, the great devotions, and

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

spends himself in a worthy cause, who at best knows achievement and who at the worst if he fails at least fails while daring gre

.

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

atly so that his place shall never be with those cold and timid souls who know neither victory nor defeat." – Theodore Roosevelt

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

Companies that provide selfless information through particip

"Many of life's failures are people who did not realize how close they were to success when they gave up." – Thomas Alva Ediso

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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