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  • E-Articles - Vitiligo

    Vitiligo is a pigmentation disorder in the human skin. The human skin contains special skin cells (melanocytes) that produce the pigment melanin which colors the skin.

    In Vitiligo, the
    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
    special skin cells (melanocytes) as well as the tissues (mucous membranes) that line the inside of the mouth, nose, genital and rectal areas, and the retina of the eyes are destroyed. As
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    a result, white patches of skin appear on different parts of the body. The hair may also turn white that grows in areas affected by vitiligo. What causes vitiligo?

    There are several th
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    eories regarding the cause of vitiligo but the actual cause is not fully known. According to one theory, people with vitiligo develop antibodies that, turn upon them and destroy their ow
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    melanocytes instead of protecting them. There is another theory according to which the melanocytes somehow attack and destroy themselves. Finally, some people with vitiligo have reporte
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    that a single event such as severe sunburn or an episode of emotional distress is the main cause of this order. Scientifically, events of this nature have not been accepted as the main
    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
    cause of vitiligo. These are merely coincidences.

    Who is affected by vitiligo?

    The number of people affected by vitiligo (http://www.antivitiligo.com/vitiligo.html ) disorder ranges fr
    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
    m 40-50 million. It forms about 1 to 2% of people in the world. 2 to 5 million people have the disorder in the United States alone.

    Vitiligo affects all races and both sexes equally and
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ninety-five percent of its victims are below the age of 40.

    What is the association of vitiligo with autoimmune disease?

    In Autoimmune diseases, a person's immune system reacts against
    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
    the body's own organs or tissues. Vitiligo is found to be more common in people with certain autoimmune diseases.

    Autoimmune diseases that are associated with vitiligo include: hyperth
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    roidism (over activity of the thyroid gland), adrenocortical insufficiency (the adrenal gland does not produce enough of the hormone corticosteroid), alopecia areata (patches of baldness
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    , and pernicious anemia (a low level of red blood cells caused by the failure of the body to absorb vitamin B12).

    Is vitiligo inherited?

    Vitiligo may be hereditary in some cases. Child
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ren of vitiligo affected parents are more likely to develop vitiligo disorder. However, most children will not get vitiligo even if a parent has it. Also most people with vitiligo do not
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    have a family history of the disorder.

    Large number of inherited disorders are associated with vitiligo. They include: albinism of the ocular type, autoimmune polyendocrinopathy syndrom
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    , congenital deafness with vitiligo and achalasia, dyschromatosis symmetrica hereditaria, ermine phenotype, familial histiocyctic reticulosis, kabuki syndrome, and the syndrome of spasti
    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
    c paraparesis, vitiligo, premature graying and characteristic facies.

    The abundance of genetic diseases associated with vitiligo clearly proves that there are a number of genes which no
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    mally govern the development and wellbeing of the melanocytes.

    What are the symptoms of vitiligo?

    White patches (depigmentation) on the skin are the foremost symbol of vitiligo. These
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    atches are more common in sun-exposed areas, including the hands, feet, arms, face, and lips. Other common areas are the armpits and groin, and around the mouth, eyes, nostrils, navel, a
    .

    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
    nd genitals.

    Vitiligo generally appears in one of three patterns: focal pattern, segmental pattern and generalized pattern. In focal pattern, the depigmentation is limited to one or o
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ly a few areas. In segmental pattern, depigmented patches are developed on only one side of the body. But in the generalized pattern, depigmentation occurs on different parts of the body


    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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