Top Adding - Communications

A Global Positioning System (GPS) usually means a GPS receiver. It is a constellation of 24 Earth-orbiting satellites. The U.S. military

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

has developed and implemented this satellite network as a military navigation system. However, later it was opened up to everybody else.

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

Examples of combination products may in

Each of this solar-powered satellite circles the globe at about 20,200 kilometers and make two complete rotations every day. The orbits o

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

these satellites are arranged so that at any time, anywhere on Earth, there are at least four satellites "visible" in the sky. A GPS rec

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

eiver locates four or more of these satellites, calculates the distance to each and uses this information to analyze its own location.

I

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

Combination pro

order to calculate a location the GPS receiver depends on two things:

- The location of at least three satellites above a person; a

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

nd
- The distance between a person and each of these satellites

The GPS receiver figures both by analyzing high frequency, low-po

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

wer radio signals from the GPS satellites. It then figures out how far the signal has traveled, how much time it has taken and how long i

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

took the signal to arrive. The receiver and the satellite then work together to make this measurement. The length of the delay is equal

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

to the signal's travel time and the receiver multiplies this time by the speed of light to determine how far the signal traveled. It is a

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

sumed that the signal traveled in a straight line and it is the distance from receiver to satellite. The most crucial function of a GPS r

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

Following aspects would a

eceiver is to pick up the transmissions from satellites and combine the information in these transmissions with information in an electro

dd to the challenges in developing combination products:

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

nic atlas, all in order to figure out the receiver's position on Earth.

Once the GPS receiver makes this calculation, it can exhibit the

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

latitude, longitude, altitude, and country grid to tell the current position of the device using GPS system. In order to make the navigat

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

ion user-friendlier, most GPS receivers install this collected data into map files stored in the memory of the device. With the help of m

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

ps stored in the receiver's memory or by connecting it to a computer that can hold more detailed maps in its memory, a person can see the

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

Professional from academic institutions, pharmaceutical industries, health care indust

detailed map of his area and find the way using the receiver's latitude and longitude readouts. Along with this information the GPS rece

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

iver also provides valuable information like odometer, speedometer, time span and average speed of an installed GPS device.

A standard G

.

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

S receiver displays the correct place on a map at any particular location. Additionally, it also traces a path across the map as the pers

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

Companies that provide selfless information through particip

on moves. By leaving the receiver on, a person can stay in constant communication with GPS satellites to see how his location is changing

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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