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Although I would rather not choose and take events as they come, I have learned that choice is inevitable.

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

With utilities like Internet choosing is becoming even more difficult.

One option that is recurring in b

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

Examples of combination products may in

usiness is the one where you ought to choose between self production and the leverage on the work of other

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

. You come across this choice in IT where outsourcing – leverage on third parties – is quite common nowada

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

ys and also the choice to tailor made a system or to buy a package that provides 80% of the functionality.

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

Combination pro

Yet in other areas, closer to home, you have to make similar selections. Sometimes you are not even awar

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

that you could choose otherwise.

Take for instance the situation where you should explain to your custom

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

er where your company is located. How does this work? Let’s say that the company in question has a website

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

on which it would like to inform potential customers and prospects. You are the webmaster or designer. Wh

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

t is your approach?

You could start with the address, than you could draw a map and finally you could giv

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

e some directions on how the get there using either car, train or bus.

The other option is to hook up to

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

Following aspects would a

software on the market that does this for you. There are plenty of geographical support tools, route plann

dd to the challenges in developing combination products:

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

rs and the like to interface to. Yet this requires a different mindset.

If you choose the first option yo

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

u can start right away, you are not dependent on others and you can tailor it to your needs and wishes. In

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

the other way you are limited by the features of the third party solution.

There are pro’s and con’s for

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

either solution. Yet, these days, networking is still gaining importance. If you can leverage on others yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

u probably get the job done with less resources, but in many times not exactly the way you want. It’s a si

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

mple dilemma that rules many business issues currently.

Your approach as a manager should be to communica

.

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 the main approach: leverage on the work of others or taking the risk of reinventing the wheel.

If you h

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

Companies that provide selfless information through particip

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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