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  • Social Space - Mexico: Party Time

    Mexico is the land of fiestas. What this word means exactly is celebration but also to indicate a party or holiday. Mexicans will have a party or celebration for any or no reaso
    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
    n at all.

    I asked my wife, who had just finished a feature article on Mexican fiestas, exactly how many fiestas Mexico has. Her response: "Only God knows."

    When I tried lookin
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    into this, I found she was right. There are so many fiestas that I found it difficult to get any accurate list of all of them.

    Here's the deal: Although there is an official l
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    st of national fiestas, each little town, and even the neighborhoods in those little towns, have traditional fiestas that they celebrate. Sometimes they make up new ones as they
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    go along! You never know and you cannot possible keep track of all of them. It is dizzying to say the least.

    Try going to www.google.com and type in "Mexican fiestas" and then
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    et ready for your eyes to bug out of your head. I got 67,800 hits for this search term. Yahoo will give you 134,000 hits. How do they do it? How do they find the time to celebra
    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 them all and just who keeps track of all of them—apparently, someone does!

    For an example, here is what is on San Miguel de Allende's calendar of fiestas:

    January – Six holi
    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
    ays

    February – Five holidays with one of them lasting 3 days.

    March – Seven holidays

    April – Nine holidays with two of them lasting 5 to 6 days.

    May – Eleven holidays!

    June
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    – Nine holidays with one of them lasting 2 days.

    July – Five holidays with two of them lasting 5 to 7 days.

    August – A slow month with only two but one lasts 15 days!

    Septemb
    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
    r – Eight holidays

    October – Six holidays

    November – Four holidays

    December – Four holidays with the Posada lasting 7 days

    The mother of all fiestas occurs in our town of Gu
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    najuato during October. It is the Festival Internacional Cervantino. This is an international celebration of the arts (some locals call it the celebration of the booze!) which l
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    asts a whopping three (count them!) weeks! Can you imagine partying for an entire 21 days?

    What I want to know is how does anyone find the time to do anything else but attend t
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ese fiestas?

    What makes my head spin is that this isn't all the fiestas. Each little town and even barrio (neighborhood) can and does have its own unique fiestas which it also
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    elebrates with all the trimmings. You can walk through a particular neighborhood and see people setting up colorful flags and banners, tables for loads of food, and hauling in w
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    atever they will need for the night's festivities. Once you hear the fireworks going off then you know the party has begun.

    The Spanish government, sometime in the 18th century
    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
    alleged that San Miguel de Allende was having "too many" fiestas. Now, what they meant by that is anyone's guess and how it was suppose to be affecting the city badly I simply
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    o not know. Nevertheless, in usual Mexican fashion (the Spaniards should have seen this as a sign of things to come), a protest was organized and lodged, and the Spaniards rep
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    aled the allegation. The point is that Mexicans love their fiestas and no one had better mess with them!

    One of the most mysterious fiestas of which most gringos know little i
    .

    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
    The Day of the Dead. This is celebrated November 1 & 2 and is not a morbid remembrance but rather a festive celebration. It is pre-Spanish and has roots all the way back to the
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    Aztecs.

    I've been to some of these fiestas and all I can say, in agreement with the words of George Carlin, American comedian,

    "One tequila, two tequila, three tequila, floor.


    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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