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  • Top Adding - Our Skating Trip Confirms My 'WHY'

    I have 2 young boys. The oldest is in Kindergarten. A couple of months ago my eldest had a field trip with his class to go skating at a rink.

    Now, in his short life, he had never
    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
    skated before ; )... but, as most young boys of 6 years believe, they can do anything and do it as well as someone who's been doing it for years!

    They have a 'take on the world
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ' attitude that makes all possibilites possible!

    The day arrived. With the entire kindergarten class, we arrived at the rink. We collected our skates, got them on and my Son qui
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ckly discovered that -first- you have to learn how to *balance* on skates!

    Then..., you have to learn how to *walk* in the tightly laced up boots with thin metal blades on the
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    bottom of them!

    Once we mastered that, the next part was stepping onto the ice...

    Have you been back on the ice, after a long period of time of NOT being on the ice? The ice is
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    lot more slippery than you remembered, right!

    My son saw some older kids get on the ice, and just start skating. So, he immediately concluded that he could do that too.

    Down h
    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
    e went, from the first step onto the ice, and then every step thereafter.

    One thing about my son - he's not a quitter. When he wants to do something of his own free will, there'
    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
    s no helping him... No one can help, not teachers, not other parents, not me, no one.

    So, I had to be patient, love him and let him struggle at it for a few minutes. Countless
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    times I asked him if he wanted to accept my help; to which I would get a very frustrated "no!"

    Now this went on for about 25 minutes like this... Him trying to get his feet un
    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
    der him... him losing his footing and landing on his stomach on the ice... Him finally getting some footing, and promptly falling down. On and on it went.

    After 25 minutes of
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    im "swimming" on the ice trying to get his footing, and then failing to stand up for more then 5 seconds on the ice, he finally accepted my help. But, just to help him to stand up
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    .

    He wanted to skate in the center of the ice rink and refused to hold on to any of the side boards - much too childish for him!

    And, he certainly was not happy with the fact t
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    hat his male counterparts from class were seeing his Mother teaching him how to skate, and helping him to get up off the ice, time and time again.

    Eventually, he learned that
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    a little help goes a long way, and he let me help. With my knees and back bent, holding most of his weight, flailing arms and legs; I was able to coach him on how he needed to get
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    his balance centered on the middle part of the skate blades [thank God, I used to Figure Skate!]

    After about an hour of this, we managed to get a grip on the movements and strok
    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
    s needed to perform the "art" of skating!

    And, after that hour was up, he could skate on his own, get up from a fall, balance and carry on skating.

    I was so proud of his perse
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    verance, and his commitment to completion - as stubborn as he was during the whole thing!

    I am so thankful that I was able to be there to give him the one-on-one coaching that
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    none of the teachers had time to give him. And, none of the other kid's parents would have been able to give him.

    More importantly, experiencing the day with my son re-confirme
    .

    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
    d that my decision to be a parent at home for my children was the right one. Because that is where my precious children need me to be.

    I am thankful that I found a home based Pr
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ogram that allows me the TIME-FREEDOM to raise my kids from home, while it works for me in the background making sales and providing what I need to support my family financially


    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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