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    Are you able to get the most out of your conversations? Especially when you o
    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
    nly have a few minutes of the other person's attention?

    Well, to do this, yo
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    u must be focused.

    Here's what I mean:

    Several years ago, I attended a netw
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    orking event at which there was a speaker who quite impressed me.

    I went up
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    to speak with him afterwards. There were many others who also wanted to speak
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    with him, so my time with him was limited.

    I did manage to have a brief con
    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
    versation with him, but I walked away feeling disappointed.

    As I drove back
    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
    home, I wondered why I felt this way.

    I realized that it was because I didn'
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    t get the information I wanted from him.

    "What did we talk about?"
    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
    I wondered.

    That's when I realized that I had wasted my precious minutes wit
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    h him.

    Although I had a specific question I wanted to ask him, I didn't actu
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ally ask it!

    Instead I meandered around, hoping he would understand what I w
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    anted to ask him. Well, he didn't.

    So our conversation ended and I lost my o
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    pportunity.

    Ever since that incident, I am very particular about formulating
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    my question or simply making sure I'm clear about why I want to tal
    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
    k with a person, before I start any conversation.

    It helps me focus.

    And it
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    helps me get what I want from the conversation.

    When I work with private cl
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ients, we can spend months on such topics.

    However, this is one very sim
    .

    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
    ple thing you can do to get started right away, towards getting the most
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    out of any conversation, no matter how brief.

    Try it out. See what happens.


    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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