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There currently are 24 operational satellites as part of the GPS satellite constellation, that orbit

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

the earth with a orbital radius of ~16,000 miles (from the center of the earth). The satellite orbits

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

Examples of combination products may in

are spaced out in 6 orbital planes (orbital plane is the plane surface formed by the path traced by

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

the orbit of the satellite – it is nearly circular). The six orbital planes are separated by an angle

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

of 60 degrees. Four to six satellites occupy each orbital plane.

In addition to the 24 operational

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

Combination pro

satellites, there currently are 6 satellites in orbit that are maintained as spares, should any of th

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

e 24 operational satellites malfunction. The six spare satellites are kept operational for users to r

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

eceive signals from them just like from the 24 satellites. However, the U.S. Government does not guar

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

antee their availability at all times.

Remember that the GPS satellites are being launched since 197

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

4. Satellites like everything else have limited lifespan. The GPS satellites have been designed to pr

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

ovide a lifespan of ~8 years. New satellites are being launched to space at regular intervals of time

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

Following aspects would a

to make up for satellites that have lived out their lifespan.

When the satellites are launched into

dd to the challenges in developing combination products:

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

space, they are inserted to pre-calculated positions in their orbital planes. The pre-calculations a

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

scertain that a GPS receiver located anywhere on earth and at all times, can receive signals from at

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

least four satellites. This is required because earth blocks the GPS signals from passing through it.

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

For a GPS receiver to be able to receive a signal from a satellite, the straight line-of-sight line

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

Professional from academic institutions, pharmaceutical industries, health care indust

should not have any obstructions in between. Since the satellites are flying around the earth, not al

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

l satellites are visible to a GPS receiver located somewhere on earth. Thus, though there are 30 oper

.

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

ational satellites, not all of them can be visible at a location on earth, at any given time.

For a

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

Companies that provide selfless information through particip

more comprehensive knowledge of GPS today, refer to websites such as www.gadgetknowledge.com/gps1.htm

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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