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The Internet has opened up a whole new world for us – bringing places we may never normally

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

see into full view right on our computer screen. Now, like never before, any computer user –

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

Examples of combination products may in

regardless of where they are – has instant access to a location that may even be thousands

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

of miles away. Web cams can broadcast live images in a matter of seconds and the Global Posi

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

tioning System – or GPS - can pinpoint an address down to the street and house through GPS m

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

Combination pro

pping.

GPS is a system of 24 satellites that continually circle the earth. The system as we

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

know it today originally began in the 1960s as the United States Navy implemented a system

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

to help submarines pinpoint their location. The United States Department of Defense – taking

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

this initial work a step forward – designed and implemented GPS. The first satellite was la

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

unched in 1978. The 24 satellites of today were not all in operation until well into the 199

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

’s. Today, we can pinpoint any location based upon the signal of the satellite closest to th

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

Following aspects would a

e location.

GPS mapping was a natural byproduct of such advancements, allowing us to harnes

dd to the challenges in developing combination products:

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

s the information provided by the satellite system. GPS mapping can find an address and inst

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

antly bring you there; some footage is so crystal clear that you can see shrubbery in the fr

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

ont yard and cars in the street.

Specific websites will allow you to simply enter an addres

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

or point of reference and information is instantaneously gathered from satellites in space.

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

Professional from academic institutions, pharmaceutical industries, health care indust

In a matter of seconds, a photo image appears on our computer screen; it’s almost hard to b

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

elieve.

Clearly, GPS has brought us into a new world of information; GPS mapping is only pa

.

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

rt of this process. It’s difficult to know what lies around the corner in the form of satell

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

Companies that provide selfless information through particip

ite information and what role GPS will play in our future. But the possibilities are endless

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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