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    A little back ground information first. I am in the 2nd year of a 3 year ESPN keepers league. 12 teams, 5 x 5 and we keep 5 players from the
    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
    previous year (I kept Pujols, Soriano, Dye, Webb and Smoltz). I feel VERY optimistic about my team, I got a lot of the players I wanted goi
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ng into my draft and it should be a great season. As much as I'm optimistic, you just never know. It's never the time to rest on your abilit
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    to improve the team. Reflect and enjoy the site of your roster AFTER you've won. Below is a quick personal critique of my lineup:

    (note: A
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ll references to Draft Round includes the first 5 rounds reserved for our 5 keeper picks.)

    C Ivan Rodriguez-(drafted round 15, last C left
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    thought could do 70 runs,70 rbis)
    1B Albert Pujols-(knock on wood, hopes everything goes well)
    2B Orlando Hudson-(after 5 years o
    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
    f mlb exp., really starting to come into his own)
    3B Alex Gordon-(see my blog for 'Potential Game Breaker Rookies')
    SS Bobby Crosb
    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
    -(sigh, I'm going to need SS)
    OF Alfonso Soriano-(will steal less this year, but in a great lineup)
    OF Jermaine Dye-(hold up on me
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    please father time, but playing for one more payday)
    OF Gary Sheffield-(Shef strikes me as a vengeful guy)
    OF Nick Markakis-(hope
    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
    ully he stays on the right uptrend track)
    OF Jose Guillen-(drafted round 25, I think I got great value here)
    2B/SS Jose Vidro-(pro
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    bably the worst hitter in mlb hitting 3rd, but I'll take it)
    1B/3B Melvin Mora-(going to need a corner hitter too)
    UTIL Milton Bra
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    dley-(if Bradley can keep it together and put it together, 25hrs/25sbs)

    P Francisco Cordero-(lets hope he doesn't start off like last year)
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    br> P Tom Gordon-(not the top notch closers I wanted, but I couldn't pass up some guys at my draft spots)
    P Bob Wickman-(one more seas
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    on.. please)
    P Brandon Webb-(lets build on last year!)
    P Curt Schilling-(playing for a contract, but I don't think he needs that m
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    tivation)
    P John Smoltz-(going through some personal issues, will use the field as his focus)
    P Rich Harden-(if he stays healthy,
    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
    going to give Johan a run for his money)
    P Daisuke Matsuzaka-(got enough horses, that a Dic-k flop wouldn't hurt that much)
    P Adam
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    Wainwright-(love his stuff, hope he can make the transition to season long starter)

    Bench Dave Roberts-(love him in a lineup with Barry Bon
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ds)
    Bench Troy Tulowitzki-(come on colorado air!)
    Bench Sammy Sosa-(each drop if he sucks, but I think he's too prideful to have c
    .

    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
    me back if he really couldn't do it any more)

    All and all, I really do like my team. Alot of hitters I like, great staff. A little weak in
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    the infield and closer situations but I'll manage and keep my eyes open for help (hint hint to everyone out there).

    LET'S HAVE A GREAT 2007


    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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