Summary - Computers and Technology

Judging by early reports the Playstation 3 is going to be one sweet machine. It will h

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

ave the revolutionary Blue-ray technology and the ability to watch and burn DVD’s. Thi

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

Examples of combination products may in

is very important as most consumers have DVD technology at the moment and it will be a

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

smooth overlap.

The Playstation 3 will be like a mini computer, with a huge amount of

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

rocessing power. Some might even say more processing power than the now released XBOX

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

Combination pro

60.

When the Playstation 2 was released 7 years ago, the average number of games sold

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

er unit sold was 5. Fastforward to the PSP; it released and has only sold about 2 games

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

per PSP sold. This is mainly because of the multimedia aspect of the game. People are

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

uying it to watch movies just as much as they are to play the games.

This doesn't soun

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

so bad, but it can cause problems for Sony. A lot of Sony's income from video game con

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

oles are the licensing fees they charge video game companies to create games on any of

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

Following aspects would a

ony's console platforms. Thus, when less games are being sold, less money is being paid

dd to the challenges in developing combination products:

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

for the rights to make games since not as many games are being bought compared to the p

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

st.

Another possible problem with the Playstation 3 is the complexity of the interface

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

. Since the Playstation 3 is so powerful, crtics are speculating that the console may c

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

nfuse consumers and give the PS3 the reputation of being complicated.

Judging by the s

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

Professional from academic institutions, pharmaceutical industries, health care indust

reenshots of games such as Fight Night Round 3 that were made for the Playstation 3 the

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

life like imaging on the games are astounding.

Watever the case may be, we will have t

.

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

wait until the release of the Playstation 3 to speculate on it’s features. One thing

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

Companies that provide selfless information through particip

f for sure, it will be a feature packed console like nothing consumers have seen before

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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