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  • Digg It - A 'Four Square' Statement

    Here's a quick and simple way to develop a strategic plan for any written document.
    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
    And while it doesn't require much actual writing, it will help you focus your attent
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ion and get a better response to your message.

    Take a sheet of paper and divide it
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    into about four equal parts by drawing a horizontal line across the page and a verti
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    cal line down the page.

    Starting in the upper-left corner, write down the germ of t
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    he idea. Take just a few words and describe the basic idea. Don't elaborate and don'
    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
    t use any space beyond that square, which will force a certain amount of conciseness
    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
    . For example, "Try invoicing occasional customers at mid-month and end-of-month, ra
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ther than just at month-end."

    Moving to the upper-right corner, concisely explain t
    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
    he 'what' and the 'why' of the idea. What will I gain by pursuing this idea? For exa
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ple, "Could improve cash flow and reduce our line of credit cost by 5%."

    Now, go to
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    the bottom-right corner and make notes about the 'who' and the 'how' involved in im
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    plementing the idea. For example, "Sales reps submit billing info by the 10th and 25
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    th of each month, billing department processes and prints invoices by the 15th and 3
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    0th."

    Finally, in the lower-left corner, explain how you will know whether or not t
    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
    he idea worked. What will you measure or monitor to see whether or not you're gettin
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    g the benefits you identified in the upper right corner. For example, "Review the ac
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    counts receivable ratios and the costs of the line of credit each month."

    Now, you'
    .

    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
    ve got a one-page summary of your idea, and while it's not a detailed plan, it shoul
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    d have helped you think through the idea, and even communicate its essence to others


    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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