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“A painting by Van Gogh. A pair of rough peasant shoes, nothing else. Actually the painting represents nothing. But as to what is in that picture, you are immediately alone with it

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

as though you yourself were making your way wearily homeward with your hoe on an evening in late fall after the last potato fires have died down. What is Here? The canvas? The brush

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

Examples of combination products may in

strokes? The spots of color?

Martin Heidegger was born in 1889 in Germany. He is considered one of the great philosophers of the 20th century. Many of the minds before him wrote a

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

out being, but never really defined being itself. His quest was to define being and his work "Being and Time," sought to answer that question. He tried to define being in human term

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 and his work influenced many thinkers, including Jean-Paul Sartre.

I look at his quote above and realize that the world is much like the Van Gogh painting. I see and feel what I

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

Combination pro

perceive it to be. I can see a blank canvas, with nothing there for me to experience. I can see an old pair of shoes and believe they are someone else's shoes, not mine. Or I can se

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

the shoes and the canvas and make up my own story about them, just as Heidegger did. All of this is up to me, through my thoughts. Through my being. The interesting thing is my wor

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

ld consists of so many paintings like this one, many probabilities for me to choose from. What shall I be today? The shoes or the canvas or the brush?

Co-creation is not a new term

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

. I do it daily in my work and leisure activities. I rarely think about me co-creating my world and everything in it. I have been trained to think about separation. Something or som

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

one is manifesting this world, I am just living in the process. I have no say in how my life evolves, God or fate or chance or genes have control of my journey. They paint the canva

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

s of my life not me. I see the results and wonder why it looks a certain way, and blame someone or something else if I don't like the end result. Creation is a term used in defining

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

Following aspects would a

God, the creator of all things. I am part of his creation, but show few signs of my creator. I can see why Heidegger was so hell bent on defining being. What is the point of being

dd to the challenges in developing combination products:

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

f I have no control over the process?

"Being is," has been a phrase used to describe the art of living. "Being without being," is another way of describing the experience. There ar

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

e many more ways to label it. But to me being is connection. It is awareness. It is understanding myself not just in human terms but in spiritual terms as well.

There is so much mo

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

re to being than I am aware of. I have many aspects of consciousness that exist outside of this focused consciousness, I call being. I can not define them all, for I have forgotten

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

hem. I am being now to remember, to expand and grow. In order to remember I have freedom, free will and the ability to think. Thoughts create matter. They create my world. If I beli

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

Professional from academic institutions, pharmaceutical industries, health care indust

eve that, I am a co-creator of my being. I am able to use my canvas and create a being that is what I believe. If I remember I am a spirit having an human experience, I am able to r

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

edefine and change my being. Being human is one brush stroke of my consciousness, not the complete work of art. Each thought adds another stroke to the canvas. The canvas is unendin

.

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

, the paint is ever flowing and the work is never finished. Perfection is changing, as I change. As Heidegger said in his book, being is always intended towards something or about

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

Companies that provide selfless information through particip

something. My being is intended towards knowing myself in more than human terms. My being is heading towards remembering who I am, and I get to pick what colors to use on my canvas

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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