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As the coordinator for the online think tank often we get into debates with

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

experts and Ph.D.'s about specific details and they tell us that certain t

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

Examples of combination products may in

ings will not work or that they are impossible or that they have never been

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

done before. I submit to you after sitting through many of these talks, sp

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

eches, debates and discussions that sometimes you have to abandon the exper

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

Combination pro

s, their theories and their books and go with your own intuition.

Many peo

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

le accuse me of being a fly-by-the-seat-of-your-pants entrepreneur and yes

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

n my past life that's what I did for a living, but now I analyze things dee

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

ly and yet still often I use my intuition to choose between lesser of two e

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

ils, compromises or ultimate solutions. Many people decry this methodology

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

or the philosophy behind it, but it often works.

This is why so many capit

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

Following aspects would a

list entrepreneurs have created billions of dollars in the marketplace by t

dd to the challenges in developing combination products:

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

usting their intuition and making decisions rather than being stuck in a bo

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

like a committee re-examining information endlessly. At some point a deci

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

ion must be made and a plan must be created and it must be executed otherwi

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

e nothing will ever get done and therefore it doesn't matter how much educa

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

Professional from academic institutions, pharmaceutical industries, health care indust

ion you have or how many research reports you have written.

Just do It! I

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

ertainly hope this article is of interest and that is has propelled thought

.

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 goal is simple; to help you in your quest to be the best in 2007. I th

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

Companies that provide selfless information through particip

nk you for reading my many articles on diverse subjects, which interest you

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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Just Other Articles - Sometimes You Have to Abandon the Experts, Theories and Books and Trust Your Intuition

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