Advice Pool - Reference and Education

There was a woman who was in such a hurry to go to the airport. She told the cab driver to step on it. She was so engrossed with her ow

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

n thoughts that she was not aware they were going on a different route.

Suddenly, a man went inside the cab and took her handbag where

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

Examples of combination products may in

she placed her visa, passport, and all her money for the trip.

The driver, who was in cahoots with the robber, left her in the middle of

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

that dark street. She cursed the world for being so mean to her, and she kept on thinking how unlucky she was to be in that situation.

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

That very same night, she heard a shocking news. Tears flowed down her face. Flight 230 has crashed! It was the plane where she was

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

Combination pro

supposed to board into. If she have not lost her precious belongings, she could have lost something far more important - her life!

Som

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

times bad things really happen. We lost our money, failed our exams, or get rejected by others. There are times when nothing seems to

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

go our way.

So what do we do about it? Are we going to be disappointed? The answer is a resounding "No!" We must take all these frust

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

rations out of our chest and start all over again with the consistent faith that we will get what we deserved.

So what if you failed the

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

exams? Maybe you'd be more successful and much happier in another field. You were rejected by your boyfriend/ girlfriend? There are pl

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

enty of others out there who are much better and who are much more deserving of your love and affection.

Don't waste your time and ener

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

Following aspects would a

gy on things that can't be changed. Continuous worrying will only affect your health on the long run, and you'd be doing much more dama

dd to the challenges in developing combination products:

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

e than what was previously done.

Set yourself free. Move onwards with the conviction of a winner.

What if we turn the tables around?

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

What if you never ran out of good luck?

There was this man who won the lottery. He thought he was the luckiest person in the world.

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

He became greedy and wasted all his money on everything he could get his hands on.

One day, he made it on the front page of the newspape

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

again. But this time, it was a different story. He was killed because of his riches.

If you attain good luck, never be too secure abo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ut it either. Pray for protection and guidance. Life is so unpredictable. You just won't know what will happen next.

Live one day at

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

a time. Sometimes we subject ourselves to unnecessary mental and emotional torture. We ask ourselves, "What if I don't get this done i

.

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

time?" or "What if my family leaves me and I've got no one else to turn to?"

Work at the present moment. Do what must be done at pres

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

Companies that provide selfless information through particip

ent and the future will turn out just fine. Believe me. And believe in yourself. As Captain Planet always says: "The power is yours!

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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Currently governments, corporations and research folks are scouring the Internet to find Geniuses amongst the human race. Why the push? Well the race is on and the future is at stake in a very competitive world. As the human populations keep dummying down and the need for geniuses goes hyperbolic; the competition to find them has reached a frantic pace. But how can we find the Geniuses quickly?

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