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    Part 1

    This report on program design is to help give you a basic, yet detailed, look at how to set up your programs for you and your athletes.

    However, it is not meant to be the definitive text on periodization,I am not trying to reinvent the wheel or promote myself as the next Tudor Bompa. (If you don't know who that is, you'll l
    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
    earn a great deal from this series!)

    Thus, this information comes from a variety of sources.

    My purpose is to provide you with information and resources to help you create better annual plans for your athletes. However, coaching is a science *and* an art. If your goal is to simply cut and paste sample programs into your own progra
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    , you are not putting in the same effort you expect from your athletes.

    Therefore you won't get very much out of this, or any, training advice.

    It doesn't matter whether you coach team sports, run 4, 8 or 12 week groups or train yourself, if your season as a whole isn't organized following specific training guidelines, then neithe
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    you or your athletes should expect to see consistent or continuous improvement.

    No periodization at all is just making things up as you go along.

    And I can't think of many situations in life or athletics where such a philosophy is a recipe for success.

    I know that the 'step over, drive down' series was a popular and much needed
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ne based on the depth and range of positive responses I got.

    With this series, I invite you to ask questions as we go along. I strongly believe that is the best way to learn. While we don't profess to have all the answers to every possible sport, training situation or scenario, we will certainly do our best to supply valuable answe
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    s to any and all questions and comments that come in.

    I find that one of the biggest misconceptions regarding training theory is that there is some universal method of training that magically applies to everyone.

    There isn't.

    There are multiple paths to the same goal. The problem comes when coaches aren't on any particular path a
    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
    all. Instead they just wander aimlessly toward some poorly defined end point, making things up based on their mood that day. Science is not used in any of their training decisions.

    This is not to say that experience and tradition don't have a role in program design, they do. But they shouldn't be the foundation of the program.

    On
    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
    top of that, let's not make training theory and program design more complicated than it is. Adding depth and detail for the sake of being fancy will take away from basic training principles that serve as the glue holding the plan together.

    In the past, I would try to add as much detail, charts, graphs and testing protocols as I co
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ld think of to my programs. I thought this would get better results.

    Well unless you coach full time, you don't have time for that. And all it will do is add more to an already full plate.

    Just like I always advocate the 'train smarter, not harder' philosophy with training, I also employ the 'coach smarter, not harder' mindset whe
    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
    it comes to organizing and planning training.

    Don't forget, a well thought out program doesn't absolve you from having to teach running mechanics, drills, etc. In fact, it makes those issues all the more important.

    But you should still factor in the amount of time you have to commit to program design before you get in over your h
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ad. I always wish I had more time to add more details to my training programs, even the ones that result in state champions.

    There is no such thing as the perfect plan. Plus, any plan must account for the fluidity of your season. What I mean is, s*** happens.

    Your athletes may be excessively sore, rain may keep you inside, cold we
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ther could make it unsafe to get that speed workout in, a competition may get rescheduled, an injury could occur, school could get cancelled.

    All of these things will force you to adapt to the current situation.

    That is why it is so important for you to take the time to learn how and why certain things affect athletes. You need to
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    be able to make changes to your training plan on the fly without it throwing your entire season into chaos.

    If you're just cutting and pasting a sample program and calling it your training plan, what will you do when forced to improvise?

    It's the same reason why I don't write out every workout of my season in advance. I learned th
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    hard way that once your schedule gets thrown off once, that whole plan has to be amended. You'll need to plan what you want to get done in detail and in advance.

    But always have a plan B that affects the body the same way as Plan A.

    OK, so that is a very quick overview covering some of the things you should be thinking about as y
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ou begin to acquire new information.

    You'll want to go out and start making changes in your program and in your training.

    This is the art of coaching. Learn something new, apply it to your athletes and see what works for your situation and athletes and what doesn't.

    Next topic: I have found that one of the biggest problems in ha
    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
    ing this discussion is that of different coaches using separate terms to describe the same things.

    Therefore, before we really get going, it is critical that we be on the same page regarding our use of terminology. I will be using terms that may not be familiar to you and that could cause confusion.

    So, check out this link and fam
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    liarize yourself with the terms and definitions so that we don't encounter any unnecessary road blocks along the way:

    http://www.completetrackandfield.com/track-definitions.html

    Bookmark that page, print it out or add it to your favorites, but make sure you can access it at your convenience.

    But make sure you read it all.

    Now, a
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    y well designed program revolves around one central principle.

    Without it, you can't possibly devise effective training in the longterm or the short term.

    What is that one overriding principle?

    The End Result.

    What is the goal of your training? What are your athletes training for?

    Is it to win the Superbowl? Qualify for the pos
    .

    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
    season? Peak for the State Championship?

    You can't ask for directions if you don't know where you're going.

    Designing an effective program is no different.

    I want you to think about a few things for next week.

    What is your end goal? Is your current or past training designed specifically to help you or your athletes be at their
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    est when that day arrives? Or does erratic, inconsistent training prevent you from getting there in the first place?

    When you really sit down and think about it, how organized and specific is your athletes' training?

    In Part II we're going to break down the most important principles involved in designing an effective training plan


    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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