Summary - Reference and Education

What is a genius? One of the best definitions of genius, which I have s

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

een in many psychology research papers is that a genius is the eminent a

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

Examples of combination products may in

hiever and therefore it is really easy to pick them out of society becau

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

e they are the people who are doing well in industry academics, governme

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

nt and the sciences. They end up at the top of the food chain because t

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

Combination pro

ey are able to work at very high levels and make fewer mistakes.

This p

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

opels their careers and yet if you interview a genius and ask them how 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

hey did it; they will generally say something like:

I was just

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

ucky

I was in the right place at the right time

The card

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

just seem to fall my way

I was working with a very good team

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

> And these geniuses will blame it on all kinds of other things ex

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

Following aspects would a

cept the fact the they are a genius. In the right place at the right tim

dd to the challenges in developing combination products:

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

; hardly? Many of them when asked actually believe this to be the case,

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

ut is it reality? Are Those We Consider Creative Geniuses just Lucky?

I

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

ndeed, if geniuses are really just lucky and they are not geniuses at al

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

. Geniuses are geniuses for a reason and they will be eminent achievers

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

Professional from academic institutions, pharmaceutical industries, health care indust

in whatever they do or where ever their career takes them.

I certainly

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

hope this article is of interest and that is has propelled thought. The

.

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

oal is simple; to help you in your quest to be the best in 2007. I thank

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

Companies that provide selfless information through particip

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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Summary - Are Those We Consider Creative Geniuses Just Lucky?

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