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For any of us who have been lost while driving, the road map has been our guiding light, identifying r

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

oadways and landmarks to help us find our way. But gone are the days of tri-folded paper maps that req

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

Examples of combination products may in

ire the use of illumination and attention taken from the road. The modern Global Positioning System –

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

r GPS – has transformed the process by which we find our way. But, contrary to popular belief, GPS nav

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

gation is not a new invention designed for strictly consumer use.

The Global Positioning System marke

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

Combination pro

its beginnings in the 1970s but seeds of its existence were sown prior to that. We first saw the poss

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

bilities of satellite navigation with the launching of Sputnik in 1957. Russian scientists who were mo

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

nitoring the progress of Sputnik found that they could track its movement based on radio waves; this s

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

t the foundation for GPS. The U.S. Navy used an elementary form of GPS in the 1960s when they used six

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

satellites to help their submarines pinpoint their location. But GPS as we know it was designed and im

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

lemented by the U.S. Department of Defense in 1978 when they launched the first operational satellite.

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

Following aspects would a

Today, 24 satellites circle the earth and provide an enormous amount of information in terms of plott

dd to the challenges in developing combination products:

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

ng location. A derivative of this technology in modern times has been GPS navigation – a system that a

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

lows drivers to map their routes. GPS navigation comes in a portable unit that can be removed and tran

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

sferred from vehicle to vehicle when needed. But because of the growing popularity associated with thi

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

system, GPS navigation units are now mounted as standard equipment in newer cars. Of course, GPS navi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ation is also essential to water navigation as used by boats and ships.

But GPS navigation is not sol

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

ly for the use of vehicles. Outdoor enthusiasts – with an eye towards safety – will often carry a hand

.

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

held GPS navigation device; the modern equivalent of a compass.

GPS navigation has allowed us to expl

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

Companies that provide selfless information through particip

re new terrain as we venture forth with confidence, knowing that, no matter what, we will find our way

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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