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    Delivery of dedicated bandwidth services to meet business data network requirements is evolving at breakneck speed (no
    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
    pun intended). But that doesn't mean your options are limited. In fact....it really creates more opportunity to be cr
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ative.

    Case in point is set up of DS3 connectivity for local loops.

    According to my knowledge nowdays most of the DS3
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    drops are connected by fiber. But is that description entirely accurate?

    DS3 hand-off is always done as copper. Howev
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    r, I've never heard of any LEC stringing coax DS3 cables across telephone poles; the coax DS3 is used within the buildi
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    g where the hand-off takes place.

    To ride between buildings (e.g. to the CO), DS3 is muxed-up to OC3 or higher. This m
    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
    eans that to get a single DS3 into a building with no fiber yet, the LEC will trench fiber into the building and instal
    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
    an OC3 mux...very expensive.

    DS3's themselves are definately copper (Coax w/BNC connectors).

    They commonly are broug
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    t in via a SONET Fibre system (aka. a single channel on an OC3/STS-1). Thus perhaps the confusion.

    If you require mor
    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
    than 1 DS3, the provider will usually drop an OC3/OC12 SONET MUX/ADM on your premises; and mux the multiple DS3's into
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    a SONET/OC3-OC12 signal for delivery into the Telco Metro Network.

    However, "your" interface (i.e. your side of the DE
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    MARC) is always Coax/BNC, one pair of coax (Tx/Rx) per DS3. The fact that the local telos may employ a SONET/Fibre faci
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ity is irrelevant to you for all intents and purposes.

    The only Caveat to that, is if you *also* have your own SONET A
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    M/MUXing equipment. You could request 3 x DS3's, but ask that the Telco bring it in on a channelized OC3 (3 x STS-1's);
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    and you would DEMUX the DS'3s from the SONET signal yourself.

    This is what quite a few business do - for example they
    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
    ay have a bunch of Nortel OM3500 OC-48 Transport Nodes, and usually request their carriers to drop any leased DS3's to
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    them on SONET APS 1+1 OC3/OC12 links; after which they can then run protected SONET/Fibre to their equipment.

    These bu
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    inesses would then Mux/Demux the DS3's themselves. However, the *all* still terminate as individual Coax/BNC connection
    .

    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
    on their own internal DSX-3 termination panel.

    So....yes both copper and fiber are involved in obtaining a DS3. But
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    he exact configuration is not as limiting as it may appear....and creativity in a final solution is definitely possible


    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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