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Over the years having been engaged in article writing and running a think tank, often o

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

ne considers the artistic talents one possess and where it all comes from. Recently I m

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

Examples of combination products may in

t a creative genius artist, poet and writer and wondered how other people come into suc

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

a mindset. What makes them tick? Are all creative geniuses alike? Maybe someone should

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

write a book on this subject and make it available for up and coming creative geniuses

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

Combination pro

to help them reach their goals.

So, it appears I have decided to do just that with the

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

help of another creative type and perhaps take some of my pre-written articles, fancy t

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

em up and make introductions to the chapters and add in some dialogues between artists

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

o that all these internal questions that creative people have can be answered.

Is it f

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

air to take pre-written articles that have been published on the web and make them into

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

an eBook? Well if you have written them before and then one is going to add lots of con

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

Following aspects would a

ent, then sure it is okay to have some old stuff in there, and one can mix and match; p

dd to the challenges in developing combination products:

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

rhaps some drawings, etc.

If one is going to explain "creativity" and ditch some of th

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

e academia theory for the reality of the minds of creative folks like you and I, then o

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

e must demonstrate it and visualize it to teach it. Trying to use a structured way of t

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

aching creativity is a complete oxy-moron.

Thus, by showing the creativity production

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd examples one can show how it all comes together and how to really ignite the passion

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

and creative juices of the hypersonic soul. You know what I mean? I certainly hope thi

.

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

article will help you if you are considering writing a book on the creative process or

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

Companies that provide selfless information through particip

some other aspect of the human psyche? Perhaps this article will propel thought in 2007

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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