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    Games have always played an integral part of man’s childhood. It started with sticks and stones and with time evolved into powerful mind stimulating games that could be played indoors. Not all children are physically capable of playing all kinds of outdoor games which they fantasize of. With imagination comes invention and with that the birth of video games, where one can sit at home and experience everyt
    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
    hing outside it.

    In 1949, Ralph Beer got an idea to build a kind of game set into a television. It was eighteen years later that many actually worked on the idea to turn it into a reality. Willy Higinbotham designed a kind of tennis game which could be played on an oscilloscope. From then on many people started developing similar kind of video games. But what mattered more than just the people inventing
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    it were the companies manufacturing these video games. The original companies who started mass scale production of these video games are Atari (an American company and one of the first), Sega (which became very successful in the field), Magnavox (a Phillips company) and Nintendo (one of the leading video games manufacturer). Soon a new era of video game technology started off with the invention of the Vid
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    o game consoles. A video game console is a dedicated electronic device designed to play video games where the output is basically through a monitor of some kind like a television or computer screen. The main input device is a controller (like joysticks, paddles, light guns, steering wheels etc.). Video game consoles started of around 1972 onwards like that of Magnavox Odyssey, Coleco Telstar etc. soon get
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ting upgraded to cartridge based 8-bit console systems like Atari 2600, Intellivision, Vectrex etc. which later developed into 16-bit systems like the Sega Nomad, Supervision, Phillips CD-I etc.

    Then came the 32/64- bit consoles like the Wonderswan Color, Nintendo 64DD, Apple Pippin etc leading to the modern era of hand-held PDA technology based video game consoles developed by companies like Microsoft
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    the Microsoft Xbox -2001), Sega (Sega Dreamcast) and Sony (The Play station). Then is the present technology of modern portable video game consoles with in-built hard drives of which the most popular are the Microsoft Xbox-360 and the Sony Play stations.

    The Sony Play station 2 (a predecessor to the Play station 3 set to be released in spring 2006) was first released on March 4th, 2000 in Japan. Soon it
    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
    had become one of the most popular products becoming the most selling video game console of the present generation selling over 900,000 units in the first week itself. It successfully competed against the then Dreamcast technology though its ability to play DVDs. Though the Sony Play station 2 had inferior graphics as compared to the Microsoft Xbox- 360 but it has a wide collection of different kinds of g
    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
    mes pertaining to various genres. In 2002 Sony launched the PS2 online adapter to compete with the upcoming online consoles developed by Microsoft. In September 2004, with the launch of the best selling game Grand Theft Auto: San Andreas, Sony released a new smaller PS2 also later manufacture of better versions which were slimmer. The basic features of the Sony PS2 includes its ability to read both CDs an
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    d DVDs, its support of PS1 memory cards, USB and IEEE 1394 expansion also replacing its earlier version Dual shock controller with Dual Shock 2 controller with upgraded shoulder and D-pad buttons also upgrading software allowing faster playback and finer textures and better graphics for the Play station games. The Sony Play station 2 also has the feature of online gaming using the Network adaptor built in
    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
    o the SP2. The Sony PS2 also has released a Linux operating system version along with an Ethernet adaptor and also a free YaBasic interpreter on the bundled demo disk which allows simple programs to be created for the PS2 by the end-user. Also a port of NetBSD project is made available in the PS2. Also mp3 and Divx movies and homebrew programs running in consoles with a modchip installed can be viewed on
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    the Sony Play station 2. Additional controllers, modem, DVD remote control, memory cards, antenna cables, component video accessories, headsets etc. are made available as additional hardware in the SP2.

    The Microsoft Xbox 360 is Microsoft’s latest video game console released in November 2005. This piece of modern technology game console is all set to compete other such consoles such as the Dreamcast and
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    the Sony Play stations including the Sony Play station 3 due to be released in spring 2006. The Xbox 360 has features which include a hard drive, online gaming support, headset, a wireless controller, Ethernet cable. Its hardware is based on an IBM power PC- based CPU and also a graphics processing unit equipped with 512 MB of RAM and also uses DVD-ROM support for game software. It comes at a modest $399.
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    9. It has the ability to support up to four wireless controllers with USB support just like the Sony Play station 2 though it has wireless technology and green LEDs. This console comes with a detachable external hard disk drive allowing storage of games, movies, videos and just about everything. Additional hardware includes audio and video cables for extra support, a rechargeable battery pack, memory unit
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    s, and universal media remote via IR etc. The DVD-ROM also supports other formats like the CD-ROMs, MP3 etc. The Xbox 360 has a 7.95 GB of storage available on the DVD though the upcoming consoles like the Sony Play station 3 will use about 25 to 50 GB Blu-Ray Discs. The Xbox 360 is totally portable just like the PS2 weighing a mere 3.5 kg. The X-Box 360 also comes with Media Center Extender capability an
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    also opens up facilities of custom music plugged in with mp3 players; ipods etc. through USBs and has the additional feature of backward compatibility. While each console is struggling to keep up the competition with the others in the market, the Sony Play station and Microsoft Xbox 360 have emerged as the leading sellers in the video game consoles market. Comparing both the products is nearly impossible
    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
    owing to their unique features compete each other in their own way. With Sony all set to release the Play station 3 in 2006 the question is as to who will rule the gaming market of the future?

    While the Xbox 360 clearly has better graphics than the PS2, PS3 completely beats the Xbox when released with support of true 1080p displays though the Xbox HD media center extender clearly makes the Xbox 360 the
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    aster of digital media allowing external mp3 player connectivity for custom music while the PS3 has no feature as such. The Xbox is powered with a 3.2 GHz PowerPC with 3 dual-threaded processor cores while the PS3 has a 3.2 GHz Cell processor with 7 synergistic processor cores (not directly compared with the Xbox). While the clock speed of the Xbox is 500 MHz that of PS3 is 550 MHz. But the Xbox has video
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    RAM of 512 MB RAM while PS3 comes with only 256 MB whereas the video memory bandwidth is almost the same. Then the Xbox comes with one 100 Mbps Ethernet port while the PS3 comes loaded with a 1 Gigabit Ethernet port. Cost wise the PS3 is aimed to hit the markets with a low price as compared to the Xbox 360 though it is expected that Microsoft would reduce their prices once PS3 is released to stay in the
    .

    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
    ompetition. So as far as graphics are concerned the Xbox comes loaded with ATI graphics core while the PS3 puts up a pretty decent competition with its NVIDIA graphics processor. Memory wise the Xbox beats the PS3 with its huge 512 MB of dedicated memory as compared to the PS3’s 256 MB of XDR memory. When it comes to the Networking part the Sony PS3 is all determined to maintain the top position with its
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    built-in Ethernet adaptor which includes an 802.11 b/g wireless adaptor while the Xbox 360 includes only the adaptor while the wireless comes at an added extra price tag.

    Overall it is nearly impossible to make a choice between these two fully loaded tech-gadgets of the Next Generation. Which of these will make it to the topmost position would only be decided once Sony releases its Play station 3 in 2006


    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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