Your Space - Self Improvement

Every industry has super innovators and creative geniuses. These are the peop

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

le who make change, but for such original thinkers they must have massive amou

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

Examples of combination products may in

ts of data and information input. Indeed that information input must also spa

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

n across several industries or industry sub sectors to do any good.

The creat

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

ve genius typically borrows information and ideas from other industries and br

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

Combination pro

ngs them together into their specialized domain. How can an innovative or ori

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

ginal thinker find information that is valuable to their thinking? As the coo

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

dinator for the online think tank I asked this question of our members.

And I

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

decided with the answer that I got I would put it to use and try it out. Today

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

I take industry magazines and trade journals from 22 different industry sub s

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

ctors. I also subscribe to over 70 online newsletters that I scan each and eve

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

Following aspects would a

y day. I have also watched every Discovery Channel program ever made and quick

dd to the challenges in developing combination products:

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

ly scan through all the periodicals that I can get my hands on.

So far my lit

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

le experiment is working and whether or not I am a creative genius or just an

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

riginal type thinker is irrelevant because it works. More people ought to try

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

it and see if it works for them as well because we need more people who are or

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

Professional from academic institutions, pharmaceutical industries, health care indust

ginal thinkers, as our society is turning into a beehive of political correctn

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

ss.

I certainly hope this article is of interest and that is has propelled th

.

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

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

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

Companies that provide selfless information through particip

thank 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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