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GPS receivers are used for such a wide variety of applications in our modern world. We find them in automobiles, airplanes, watches, cell phones, a

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

nd various other handheld and built in devices, providing the military, the business world, and individuals with valuable information instantly 24 h

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

Examples of combination products may in

ours a day. GPS can be used to find addresses and directions, show travel routes, determine the speed of travel, and several other helpful types of

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

instant feedback that can be used for many purposes. The use of GPS with exercise programs has become increasing popular in recent years with the

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

availability of GPS watches, cell phones, and other handheld receivers. These have proved to be extremely useful for biking, hiking, running, walki

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

Combination pro

ng and many other forms of mobile exercise. Almost every version of GPS receiver (GPSr) has a trip function for instantly calculating time elapsed,

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

time moving, time stopped, average speed, and current speed, which are all very helpful for training and exercise in various sports and activities.

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

Many exercise walkers have heard of, or even use, a pedometer. These simple, inexpensive devices actually count the number of steps and calculate

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

distance by the length of steps, but they are very inaccurate and difficult to set correctly. Compared to GPSr, they produce very primitive result

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

s. A GPSr does not know the number of steps or the length of steps, but it does provide your exact location according to multiple satellite transmi

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

ssions. Trying to maintain a certain speed or keep track of distance is incredibly simple and accurate. The average speed display available with m

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

Following aspects would a

ost GPSr's will quickly show how fast the walker is moving. Keeping track of distance is just as simple. If a walker wants to go a certain distanc

dd to the challenges in developing combination products:

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

e and then return, all they need to do is glance at the receiver to find the distance traveled. If the route needs to be changed or considered, a G

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

PSr map function will display the surrounding area and the walker's current location.

For training and racing, GPS can help individuals reach speci

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

fic points and specific times and help them to accurately pace their route. This is done through another GPSr function called the waypoint functio

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

n. Waypoints are previously stored coordinates that plot a route in advance. As a runner or biker progresses, the GPSr can show the progress of th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e person in comparison to the waypoints and provide the distance to the next check point or turning point.

After completing a race, training sessio

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

n, or regular workout, the GPSr tracking information can be recorded in order to monitor progress. By recording total times, distances, averages sp

.

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

eeds, etc, an individual can easily determine goals and continue steady progress towards those goals. Once most athletes and exercise enthusiasts u

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

Companies that provide selfless information through particip

se a GPSr to supplement their workout, they never go without it again. The kind of information that GPS provides is simply too useful to do without

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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