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The Global Positioning System (GPS) is a satellite-based navigation system owned and developed by the United States Department of Defense. It is officially named NAVSTAR (NAVigation Sate

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

llite Timing And Ranging) GPS. During the 1980s, the United States government made the GPS available for public use for free. It can be used from anywhere in the world and is operationa

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

Examples of combination products may in

24 hours a day. The GPS consists of three segments: space, control and user.

The space segment includes a network of 24 GPS satellites that is managed by the United States Air Force.

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

he satellites are spaced so that at least four satellites will be above the horizon from any point on Earth. These satellites are enough to determine the location of a GPS receiver anywh

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

re on earth. They orbit the earth every 12 hours at an altitude of about 12,000 miles. They travel at speeds exceeding 7,000 miles an hour.

The control segment consists of a master con

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

Combination pro

rol station, monitor stations and ground antennas. Monitor stations track the orbits of the satellites and this data is sent to the master control station. The master control station re

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

gularly uses the ground antennas to send updated orbital path information to every one of the satellites.

The user segment consists of the GPS receiver. The receiver has an antenna that

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

allows it to acquire the signals sent from the satellites. A receiver can have between 12 and 20 channels. The number of channels indicates how many satellites it can monitor simultaneo

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

sly.

Here’s how all these segments work together. Each GPS satellite contains a computer, atomic clocks and a radio. Each satellite constantly broadcasts its current time and current l

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

cation. All of the satellites broadcast their information at the same time. A GPS receiver can calculate its exact position by determining the distance between itself and three or more

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

atellites. The time between a signal transmission and reception will allow the receiver to determine the distance to each satellite. When the receiver gets the distance measurements fro

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

Following aspects would a

m three or more satellites, the exact location of the receiver can be determined. This process is known as triangulation. If the receiver can display a map, its position can be shown on

dd to the challenges in developing combination products:

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

the map. The position can be determined within 10 to 100 meters. If you have special military-approved equipment, the position can be determined within 1 meter. In addition, the clock

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

n a receiver is not as accurate as the atomic clocks in the satellites. This is why receivers track one or more additional satellites to correct any clock errors.

A GPS receiver can cal

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

ulate its two-dimensional position (latitude and longitude), if it acquires signals from at least three GPS satellites. A GPS receiver can calculate its three-dimensional position (latit

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

de, longitude and elevation), if it acquires signals from four or more GPS satellites. The receiver can not only determine its exact location; it can also determine speed, direction of t

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

Professional from academic institutions, pharmaceutical industries, health care indust

ravel, distance to destination, estimated arrival times and more.

If you want to ensure the highest accuracy, a GPS receiver should have a clear line of sight (unobstructed view) of the

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

PS satellites. This means that it should be used in the outdoors. A GPS receiver will not work indoors, underground or underwater. Buildings, overpasses, forested areas, or electronic

.

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

nterference can shield the receiver from a satellite. This can weaken the signal from the satellite and cause the receiver to give unreliable readings. Another problem that may occur is

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

Companies that provide selfless information through particip

multipath interference. Multipath interference occurs when a signal from a satellite to a receiver is delayed because it was forced to bounce off of tall buildings or large rock surfaces

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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