Actual - Communications

GPS - What is it?

The Global Positioning System or GPS for short is the world’s first satellite radio-navigation system. It was developed by the United States Department of Defense under the name of N

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

AVSTAR or Navigation Satellite Timing and Ranging. Research on timing and navigation by a satellite arrangement began in the 1960’s with the first operational GPS satellite launched in 1978. However it

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

Examples of combination products may in

as not until April 27, 1995 that it became fully operational. Originally they were used primarily for troop navigation and positioning and for artillery fire. In the 1980's the U.S. government by exec

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

utive decree authorized its use by the civilian population.

The GPS System is made up of three main elements, Satellites, Earth Monitoring Stations and GPS Receivers. Presently there are 24 satellites

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

ircling the earth in 6 orbits. Each satellite circles the earth twice a day traveling at approximately 7000 miles per hour. At their highest point they orbit about 12,600 miles above the earth's surfa

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

Combination pro

ce. At this height the signals from each satellite can be picked up over a large area of the earth's surface. This is important since it offers at least four signals that can be picked up by your GPS

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

eceiver. The more signals used to pin point your location the more accurate your reported location will be. Working with the satellites are five monitoring stations located on earth. Four of these st

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

ations are unmanned and the fifth is a manned master station which is located in Colorado Springs, Colorado. The four unmanned stations constantly receive position data from the satellites and send it

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

n to the master station. The information received by the master station is used to correct the position of the sat tiles and then sends that corrected information back to the satellites. All of this o

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

ccurs so that the third element your GPS unit receives accurate data from the satellites it is receiving signals from at any particular moment. Your GPS unit then takes this information and reports to

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

ou by signal and screen information your exact location.

The signals sent from the GPS satellite system are low power radio signals. They are "line of sight" signals like your cell phone signals. Thi

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

Following aspects would a

s means they pass through clouds, glass and plastics but not through solid objects, such as buildings, in basements, caves, etc. Weather conditions also affect GPS signals, however not enough to affect

dd to the challenges in developing combination products:

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

the quality of the signal your GPS unit receives. Since GPS satellites cycle the earth, their signals can be picked up and used anywhere on earth. No fees or setup costs are needed to use the GPS sate

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

llite system.

Your GPS unit works by calculating the time it takes to receive a signal from each of at least three satellites comparing that to the reported location of each of those reporting satellit

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

s and then through triangulation techniques identifies its and your exact location at that moment.

It is possible by receiving signals from just three satellites to give your position by latitude and l

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

ongitude and to report or track movement. However, when your GPS unit is able to receive signals from at least four satellites it can calculate your position in 3D. That is, it can report your positio

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

Professional from academic institutions, pharmaceutical industries, health care indust

with latitude, a longitude and an altitude. With this information your unit will be able to report not only position and movement but it can report your speed, trip distance, distance to a destination

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

, and more.

The accuracy of your GPS unit depends on its ability to quickly receive and hold onto, or lock on to, a GPS satellite’s signal. The ability to maintain a strong lock on that signal while y

.

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

ur GPS unit is in dense foliage or urban settings with tall buildings and how it deals with weather factors such as snow and electrical storms depends on the features designed into your unit. Generally

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

Companies that provide selfless information through particip

less expensive units will have accuracy's averaging between 30 to 40 feet. Newer more expense GPS units pickup more satellite signal, retain them longer and increase accuracy down to just a few meters

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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