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A beggar had been sitting by the side of the road for over 30 years. One day a stranger walked by, "Spare some chang

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

e?" mumbled the beggar, mechanically holding out his old baseball cap. "I have nothing to give you," said the strange

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

Examples of combination products may in

r. Then he asked: "What's that you are sitting on?" "Nothing," replied the beggar. "Just an old box, I have been sit

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

ting on it for as long as I can remember." "Ever looked inside?" asked the stranger. "No." said the beggar. "What

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

's the point? There is nothing in there." "Have a look inside," insisted the stranger. The beggar managed to pry o

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

Combination pro

pen the lid. With astonishment, disbelief, and elation, he saw that the box was filled with gold.

--Eckhart Tolle, T

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

he Power of Now

Eckhart Tolle used this powerful story to open his book "The Power of Now."

If you think abo

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

ut the above quote by the author of The Power of Now, a bit more deeply, you will realize that everything you

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

need or want exists already within you. All you have to do to be open minded. Find the key and crack open the box to

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

your consciousness, your knowledge, your innermost treasures that operates behind the scenes.

You have it all inside

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

you.

You probably say to yourselves: "Sure it is easier said than done!" How a simple person like me can crack open

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

Following aspects would a

the box to my consciousness?

Well, for starters, how about first believing that you posses all the knowledge. Your

dd to the challenges in developing combination products:

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

consciousness is your Higher Self, your Higher Power that operates behind the scenes. It is the real you. Everything

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

you need is stored there. Just like your DNA is there all the time. Your job now to unleash your Inner Power.

Take t

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

hese steps to:

1. Be more receptive

2. Be more open minded

3. Be more open to new ideas

4. Become an adventurer

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

5. Take risks

6. Experience the real life

7. Exercise your God given talent

YOUR LIFE WILL RESPOND TO YOUR BELIEFS

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

Professional from academic institutions, pharmaceutical industries, health care indust

The dreams you choose to believe in come to be. When you feel in your innermost being that you will achieve what yo

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

u set out to do, you open the way for miracles. Choose to believe something good can happen. Expecting it to happen e

.

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

nergizes you and actually gives it momentum. What you expect to happen, happens.

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

Companies that provide selfless information through particip

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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