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Team= Together Everyone Accomplishes More or so the acronym says. We

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

often hear about teams in sports, military, corporations and politic

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

Examples of combination products may in

s. But team dynamics can also be found in very low-tech businesses.

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

Consider if you will a crew of mobile car washers or mobile fleet veh

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

cle washers.

A crew of mobile car washers may have up to 4 people on

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

Combination pro

the crew and a team of mobile fleet vehicle washers may have five or

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

more on the crew and if they operate in an efficient manner like the

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

sports team; the company will make it a lot more money and they will

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

get each job done sooner so they can do more jobs.

One way to build

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

a strong team on a mobile car wash business is to make sure the team

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

leader is a high-energy person with some athletic experience. Once t

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

Following aspects would a

he crew starts egging each other on the real synergy can be developed

dd to the challenges in developing combination products:

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

and they can pick up the pace.

Having been in the mobile car wash bu

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

siness for over 27 years I can tell you when working with new franchi

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

sees that once the team got good working together it was incredible t

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

he number of cars that could be washed in a single day.

I can rememb

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

Professional from academic institutions, pharmaceutical industries, health care indust

r times where we would pull into a parking lot and our competition wo

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

uld be their detailing or washing a few cars and we might wash and wa

.

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

x some 15 cars and leave, while they were still working on two cars.

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

Companies that provide selfless information through particip

Why, well together everyone accomplishes more. Consider this in 2006

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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