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Sometimes you need to go back in time –- say four hundred years -- to understand that things have not changed. The movie Luther showed

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

me that. What happened in the beginning of the sixteenth century is still of present interest.

Where a historical drama can never really appr

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

Examples of combination products may in

oximate history as it really was, there is one very interesting aspect with a contemporary influence; language differences and the role of kno

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

wledge.

We all are aware of the importance of knowledge and that knowledge is the oil that keeps the economic motor running. Yet knowledge is

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

also many times a problem. Organizations often depend on single employees or managers knowing how to manage certain activities. And then, the

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

Combination pro

various departments use different languages and to manage activities from end-to-end is a real challenge that is common to any organization.

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

Somewhere at the end of the film -– and I’m glad I saw it because my knowledge of history didn’t reach that far –- Luther started the translat

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

ion of the bible into German. Why?

You can find many different languages in business but the main opponents are the commercial and the tech

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

nical language. A commercial language is obviously uttered in the area of sales, and it is not so much the language itself but its focus on th

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

e market; what’s happening out there? A commercial language could be seen as the language of the demand side. What people want or need, what t

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

ey see, buy...The day to day communication. The language of emotion.

The technical language is a language that is spoken where things are con

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

Following aspects would a

structed, an internal language focused on how things work and function. A technical language is used to build a car, understanding how the mot

dd to the challenges in developing combination products:

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

or works. A commercial language is what you need when you want to sell the same car.

Before Luther, the bible was available in Latin or Greek

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

.

That’s why the Roman Catholic Church members could easily sell indulgences. Nobody -– on the street -- really understood what was going on.

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

It was Latin to them. So they bought these, for a better life (afterwards). Luther changed this practice. He translated the script so it was

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

open to the public. Did he commercialize the bible? I wouldn't go that far...

One of the aspects of knowledge management is opening knowledge

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

Professional from academic institutions, pharmaceutical industries, health care indust

, making the tacit knowledge that is somewhere locked-up in the minds of individuals, open for the group. Making it explicit. In organization

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

s, this is not seldom about making technical knowledge available for others. Translating the technical writings into a more commercial languag

.

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

e. So what now?

Different languages will always exist. Where different teams with different background meet, you should always reserve time

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

Companies that provide selfless information through particip

to translate, to bridge the gaps. Don't forget to put it somewhere on the agenda if you think it applies in your situation.

© 2006 Hans Boo

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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Offshore incorporations mean anonymity, no or limited liability, high tax exemptions and revenue benefits and asset protection. If you deal in a business that faces too many hassles under your domestic jurisdiction then offshore incorporation under a favorable jurisdiction can be quite fruitful. Many countries have more flexible and lenient business legislation. Therefore incorporating your business online under these legislations takes off a number of legal hassles from your head.

The author successfully explains the importance of having a professional logo design for success of any business. While most businessmen would spend a lot on other accounts, they are often thrifty while getting a logo, but isn't it important to invest in a proper logo that will be the face of your company to the world?

Lean manufacturing is something that is very well known these days as more and more companies seek to follow a tradition started by Toyota Production system.

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