E-Articles - Self Improvement

The first steps of a child are always the most joyful! Children think in images. Their consciousness is not socially conditioned yet. Their first drawings, the first signs on paper, make a lot of sense to them.

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

They put all their emotions in the first paintings. They create. They are direct. They are artists. Each of us has a little child - an artist inside. In each and everyone of us is a direct perception of the wo

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

Examples of combination products may in

rld around us which speaks to us. We need to express ourselves, express our feelings and thoughts. This is not a desire to become an artist - we are already artists - we create - we draw - we paint- we write...

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

For children, it is not very important if the painting is an exact copy of the reality. What is important for them is how they perceive the reality and how they express themselves and their feelings on paper.

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

If you have a chance to observe a kid painting, you will be amazed how much joy and happiness he/she can experience just by drawing some simple picture. When they draw or paint, they are the creators; there is

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

Combination pro

o separate painting and painter. It is one whole process of creation.

You can do one simple experiment. Go to a kindergarten class or find a group of children about about 4-5 years old and ask them a question:

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

"Who can paint? Raise your hand." There will hardly be any child who will not raise his/her hand. Now go and find a group of adults and ask them the very same question. You will be surprised. There will be fe

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

w if any of them who will raise their hands. You may wonder: where did those artists go from within us when we grow up.

Unfortunately, when we grow up we become more and more conditioned by the environment. We

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

become more and more self-conscious about our skills. Now, we try to make our paintings and pictures to be an exact copy of the reality, and if it is not so, we get frustrated and give up. We start making excus

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

es like: I am not good enough; I don't have the necessary skills etc. But the trick is to hold on to that child-like state within us. That state gives us joy and the highest degree of happiness while we are cr

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

ating something. It is that inner artist that will guide us through the challenges and adversities of learning the skills to become a great artist. One of the greatest painters in history of humankind, Pablo Pi

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

Following aspects would a

casso, once said, "For all my life I have been learning to paint like a child". If we stay in touch with our inner child-like artist, then learning any skill will become only a matter of time and practice - not

dd to the challenges in developing combination products:

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

hing more.

What happens if we let the inner guide teach us? During the course of our lives we become more skilled in the ways of transferring our thoughts and feelings on paper. We learn to make a painting mor

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

alive and more expressive. We are now able to grasp some laws of expressing ourselves. We look at what others do, we become more and more experienced, we read books, we study. And one day, our skills become ex

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

cellent. Even other people start calling us artists. We devote all our attention and all our time to the training of acquiring art skills; we continuously think "How to draw... " And " What to draw "

Finally,

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

would like to give you a some practical advice. If you really want to learn to draw and paint, it is really necessary to paint something that is very interesting, very exciting for you. Something that really s

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

Professional from academic institutions, pharmaceutical industries, health care indust

peaks to you. You may even feel the necessity to paint it. Only then will you be able to experience the highest degree of happiness in the process of creation. And only then will your work touch others. Probab

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

ly it's worth to look at your memories, look into your subconsciousness in your early sketches and etudes. It is very easy to miss something that lays very deep in you., but those things can really prompt the 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

ner artist to find an important theme for the work. It can be absolutely habitual things, for example a picture of a yard filled by the wonderful light of a sunset or a painting of a hero from an interesting bo

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

Companies that provide selfless information through particip

ok you have just read. Look into yourself, into the artist living in you and define your work only by your feelings. Unleash the greatest artist that is already in you. I wish you much success in your creations

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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