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  • I Suggest - Women Bikers, Shifting Gears

    Freedom. Throwing caution to the wind. Oneness with nature. This is how many women are feeling about their motorcycles and they are taking the roads by storm. The notion of women being perceived as backseat ornaments on motorcycles is long past. Women are suiting up all over America and the world to experience the exhilaration that until recently mostly men had the pleasure of experiencing. They're controlling the throttle while their
    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
    husbands, significant others and men in general are embracing their new found independence.

    When it comes to forming motorcycle groups, clubs and organizations, women are setting their own standards. We should reflect on the past and give credit to the rebels who made this possible by defying the norm.

    In the 1900's motorized bicycles opened up a new world of adventure for women. Take Dot Robinson who was considered to be a pioneer i
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    the arena of female motorcyclists. Dot won her first trophy in 1930 at the Flint 100 Endurance race. She rode until she was 85. It is estimated that Dot has ridden about a million and a half miles.

    Bessie Stringfield also known as "The Motorcycle Queen of Miami" was one of the first African American women to challenge gender and race in this arena. She was known for her "Penny Tours". She would toss a penny onto a map and set out to
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ide her Harley to that location, which took her all across America. Bessie received her first Harley in 1927 at the age of 16. She joined the Army as a Motorcycle dispatch Rider during World War II. Bessie was inducted in to the Motorcycle Hall of Fame in 2002 subsequent to her death in 1993 at the age of 82.

    Let's not forget Adeline and Augusta, the Van Buren Sisters. In 1916 the sisters were the first to climb Pike's Peak a 3,300 mi
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    le trip and the first to travel from New York to California on motorcycles.

    It was the tenacity, boldness and rebellion of such women that cleared the road for today's women who ride with passion and finesse.

    In 1940, Linda Dugeau formed the Motor Mail Organization, which gave women of that era the opportunity to share their experiences with new-found friends.

    Today's women are taking the lead, continuing the trend of hitting the op
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    n road and even the race tracks, in groups and alone.

    As I spoke with Tammy Mullins about her riding experiences, I could tell she embraced motorcycle riding with great passion. As a young kid, Tammy enjoyed taking turns riding a dirt bike with friends. It was something she looked forward to every chance she got. From that point on she became hooked on the idea of riding a motorcycle. During one Christmas holiday, she was deeply disap
    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
    ointed when her brother received a motorcycle and she did not. Her parents were unaware that she had a passion for motorcycles. Over the years, Tammy continued meeting people who rode these two-wheeled wonder machines. For a long time she was a backseat rider which she admits was also a thrill. After years of not knowing how to go about obtaining a license, her husband encouraged her to take the exam. She admits that the exam challengi
    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
    ng because "you have to be aware of your surroundings. You're out in the elements and there's no padding around you such as with driving a car." No longer the backseat rider, Tammy owns and rides a Buell Blast made by Harley Davidson, which she loves because "it's loud which allows others to become aware of my presence." Tammy always gravitated toward people with bikes because it represented a sense of freedom and independence.

    Drivin
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    out in the open, the wind in your hair, feeling oneness with the road is what attracts so many people to motorcycle riding and Tammy's no different. She expresses it as communing with nature, and "it's the best feeling." Her Buell is more of a learning bike for her because she is still fairly new to the world of motorcycle riding.

    Women feel a deep sense of independence when riding their bikes that they can't get from driving a car.
    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 would like to see the motorcycle industry cater to women a little more by building bikes with power but less weight and width.

    Some dealers are now beginning to take women riders more seriously. It is a growing market for them. Companies like BMW and Suzuki are beginning to design bikes that are tailored to the female physique.

    Generally speaking, women have less upper body strength than men and many of them are not as tall as the
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    average male rider. One thing Tammy dreads is picking up her bike if it falls over.

    There is a special bond that exists between motorcycle riders. For example, the wave that motorcyclists use when they pass each other; bring your hand down to your left side and point your finger down.

    Tammy's husband Jim has been riding motorcycles since about 1975. As a teenager in San Antonio, Texas, he realized he could obtain a license for a moto
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    rcycle before obtaining an automobile license and to him this meant freedom, in a different sense. It gave him the opportunity to leave the house without his mother having to chauffer him. His mother was not too pleased about him riding a motorcycle though. He traded his first motorcycle in for a Harley and twenty years later discovered it in a private collection at a motorcycle shop. He regained ownership and plans to restore it. Acco
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ding to Jim, one of the safest motorcycles you can purchase is the BMW.

    Early on when Tammy first began riding, Jim accompanied her quite often for safety reasons and to help her gain confidence; but it was also much more enjoyable when riding together.

    Jim's view of women riders? If they want to ride, then more power to them. He suggests that first time women riders should purchase a bike that is less expensive and easy to maintain.
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    That's what Tammy has done.

    Donna Pfoff on the other hand has always been a backseat rider. It makes her feel alive and as though she's a part of the scenery that surrounds her and her husband as they glide down the road. Her first experience on a motorcycle was an enlightening one but also frightening. When her husband purchased his first Harley, she didn't exactly take to the idea. "Was I supposed to lean when he leaned? Was I to si
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    t absolutely still like I was a mannequin?," she states. As time passed she began to relax and literally sit back and enjoy the ride and the scenery.

    When Donna and her husband traveled to vacation spots on their motorcycle, they experienced some of their most glorious rides. One experience she'll never forget she says is when they rode from Cody, Wyoming to the Beartooth Mountains. Standing in the snow at a 12,000 foot elevation was
    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
    ruly breathtaking, scenery you would normally only see in a photograph.

    I gather from my conversations with the Mullin's and the Pfoff's that motorcycle riding places you in a completely different state of mind where you gently release your worries and stress as you blend with nature. Who knows, maybe I'll give it a try.

    There is a side of motorcycling that must be discussed and that is safety. On motorcycles there is no such thing a
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    a fender bender; the slightest bump will knock you off your bike. As I conversed with Tammy and her husband, they offered a few points about safety.



    • Until you become an experienced rider, be careful with acceleration


    • Always wear a helmet with a face shield or eye protection


    • Wear a heavy protective jacket with padding at the elbows, shoulders and back


    • Wear heavy boots that cover the ankles

    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

  • Dark clothing is not the best choice, especially if you are riding at night; if you choose to ride after dusk, wear reflective clothing


  • Allow tailgaters to pass by slowing down, pulling over and waving for them to pass;


  • And here are a few more points if you are new to or have an interest in motorcycle riding:

    • Take a motorcycle safety course first


    • Find friends and/or a mentor who rides
      .

      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
      >

    • Consider purchasing a used or less expensive bike


    Female motorcycle groups are extremely diverse in age, the style and make of their bikes, their professional and ethic backgrounds, and they range from novice to the seasoned fast-lane race track rider. One thing remains constant, the friendships and the special bonds that bring them together. It's not all about coming together for leisurely rides. While enjoying the
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    r new-found freedom and independence, these women are making a difference in their communities. They are participating in charities, donating gifts and riding for causes such as breast cancer. They are forming friendships that enrich their lives and the lives of people around them.

    Riding motorcycles is no longer a "man's thing", it's also a "woman's thing" and they're doing it with style. Move over Easy Rider, the ladies have arrived


    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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