Advice You - Business

The professors and instructors at the top colleges and universities in the United States and throughout the world are to be held in h

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

igh esteem for they educate the next generation that will be leading this great nation and the world. Not only does the public hold p

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

Examples of combination products may in

ofessors in high esteem, but luckily they also hold themselves in high esteem, which gives him the confidence to stand in front of st

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

dents and teach.

Entrepreneurs are always quick to criticize academic professors because they often say with much disdain; "Those Th

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

t Can't Teach!" This is the entrepreneurs way of saying; "We Are the Ones That Built Everything You See Everywhere You Go Including T

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

Combination pro

he University Itself, Not the Academics." Indeed, both could be said to have good points and both are needed. The professors are ne

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

ded to ensure that our population is educated and the entrepreneurs are needed to provide jobs, the economy and deliver the desires a

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

d wishes to the consumers and citizens.

The truth is we cannot have a civilization without them both. You cannot have Utopia until

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

omeone builds it and you probably cannot dream of a Utopia until someone thinks about it. Who has the greater insight; The academic

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

thinker or the entrepreneur doer?

In Phil Dusenberry's book; "One Great Insight Is Worth a Thousand Good Ideas," the title itself se

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

ms to indicate that without great insight all the ideas in the world do not matter. So the true issue here is who has the best insig

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

Following aspects would a

t? Entrepreneurs know how to get things done and they learn by actually doing it rather than reading about it in someone else's book

dd to the challenges in developing combination products:

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

When you read about something in a book you have secondhand knowledge and not firsthand knowledge of the situation.

Academics ofte

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

n believe that they are well-educated and smart and have better insight due to the time they spend sitting around thinking and philos

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

phizing on various issues and concepts. What most people do not realize is that entrepreneurs have to do this and they have to do it

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

breakneck speed to survive in the marketplace. They have to think fast and on their feet and get the job done. The doers do not sim

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

Professional from academic institutions, pharmaceutical industries, health care indust

ly go home at the end of the day and stop thinking, as their minds are running 1,000,000 miles an second all the time.

Thus again I

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

ask the question to which I already know the answer, but perhaps you can figure it out for yourself if you are an academic. Who do y

.

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

u really think has the best insight? I certainly hope this article is of interest and that is has propelled thought. The goal is simp

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

Companies that provide selfless information through particip

e, to help you in your quest to be the best in 2007. I 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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