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GPS (Global Positioning Systems) have been around for quite some time now. Its first use

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

was with the military, but they have more recently been associated with civilian navigat

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

Examples of combination products may in

ion devices. The latter is the topic of this discussion.

There are three components nec

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

ssary for the success of a Global Positioning System. Those components are made up of 24

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

satellites, GPS Receivers, and ground stations. Each component must work in harmony or

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

Combination pro

here will be inaccurate readings. A brief description of each and their functionality fo

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

llows.

GPS Receivers act just as their name indicates. They receive informati

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

on from the chosen satellites using radio waves to calculate their exact location. Once

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

his information has been received, feedback is provided to the user.

Ground s

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

tations have a two-fold operation. The first is to ensure the health of the satellite.

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

he second is to respond to the satellite with its exact location. This location is very

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

Following aspects would a

important as it is used to later determine the exact coordinates of a GPS device.

<

dd to the challenges in developing combination products:

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

li>Satellites determine the coordinates of a GPS device using trilateration. Basically,

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

hree satellites use radio signals to determine the total distance from the tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

//www.happyjaysgps.com">GPS device. This can become very complicated because of a va

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

iety of interference possibilities. Therefore, most civilian GPS systems use additional

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

Professional from academic institutions, pharmaceutical industries, health care indust

satellites to increase accuracy.

GPS systems continue to grow in popularit

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

y. There is a belief they will one day be as common as the telephone or television. The

.

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 is also a belief that the high popularity will help to push builders into furthering th

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

Companies that provide selfless information through particip

e technology with improvements much in the same way as the cellular phone in recent years

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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