Summary - Self Improvement

I'm a dreamer and I'm proud of it! However, sadly we live in a world that does not encourage dreamers when more than ever we need to cultivate them.

This is a wonderful ti

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

me of year to encourage dreams and dreamers. The new year is not very old and spring brings with it a wealth of new growth all around us.

New is one of my favorite words.

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

Examples of combination products may in

The wonderful thing about the word new is the wealth of possibilities it embodies-a new baby, a new home, a new job, a new year…The beginning of a new year is especially th

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

time to dream about the possibilities it holds. Spring is also a wonderful time to make changes and enjoy new experiences. The sunlight, the new growth, and the warm air a

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

ll bring a desire, sometimes even a need, within us to do something new. What better time of year to pursue your dreams?

Dreams often get a bad rap. Dreamers are viewed as

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

Combination pro

slackers. Yet if it were not for the dreamers in our past we would not have many of the wonderful inventions that make our lives easier or more delightful (or both). Perhap

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

s it is the ability to dream far more than the opposable thumb that sets us apart. Dreams are escape it is true, but they are also plans, hopes, and wishes-and we all know

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

hat sometimes dreams come true…

Imagine a world where Orville and Wilbur Wright did not dream of soaring above the clouds or where Jonas Salk did not dream of a prevention

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

for the scourge of his time? How different would our worlds be if we had not harnessed flight and found a vaccine for polio?

Yes, these are two examples of the power of d

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

eams and why we need them. This is why it is important to allow yourself to dream-for yourself and for humankind.

Think about this quote from Woodrow Wilson: "We grow gre

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

at by dreams. All big men are dreamers. They see things in the soft haze of a spring day or in the red fire of a long winter's evening. Some of us let these dreams die, but

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

Following aspects would a

others nourish and protect them; nurse them through bad days till they bring them to the sunshine and light which comes always to those who hope that their dreams will com

dd to the challenges in developing combination products:

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

true."

Many of us have dreams that we do not dare let see the light of day for fear of failure or ridicule. Yet it is important to be brave and remember that all success

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

comes with some failure. The Wright brothers worked for 10 years toward their dream and even after it was realized there were mistakes-sometimes tragic and fatal ones.

Sal

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

did not realize his dream in one day or even one year, but spent many years building on his work as well as that of others to make it a reality.

Wilson himself achieved m

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

any dramatic successes and some even more spectacular failures.

Mark Twain had something to say about this fear of failure and its effect on your dreams: "Twenty years fro

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

Professional from academic institutions, pharmaceutical industries, health care indust

now you will be more disappointed by the things you didn't do than by the ones you did do. So throw off the bowlines. Sail away from the safe harbor. Catch the trade winds

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

in your sails. Explore. Dream. Discover."

So do as Twain advises-explore, dream, discover-follow your dreams and who knows where they will lead you. Believe in yourself,

.

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

elieve in the power of dreams, and may we all benefit from their beauty!

Nourish your dreams and protect them for the bad days will end and sunshine and light will come, b

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

Companies that provide selfless information through particip

ut only if you let your dreams fly.

I leave you with this quote from Henry David Thoreau: "Go confidently in the direction of your dreams. Live the life you have imagined.

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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Summary - Are You A Dreamer?

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