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E-Articles - What is Bipolar Disorder?
Bipolar disorder is also commonly known as manic depression. Manic depress 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 ion is a psychological disorder that is treatable, but as of yet, not cura ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in le. A person who suffers from this disorder tends to have extreme periods lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. of depression, which is then followed by extreme periods of happiness. Ma here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ic depression is divided into two types. The two types are known as Bipola d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro Type 1 and Bipolar Type 2. When a person suffers from Bipolar Type 1,the 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 ir depression period is usually low to mild. However, their period of happ 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 ness is extremely high. If they are suffering from Bipolar Type 2, the opp nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically osite occurs where by their period of happiness is low to mild, whilst the 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 period of depression is extremely high. When a sufferer of manic Bipola ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi disorder reaches an extreme form of mania, it is said that they are suffe ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a ring from hypomania. During the period of hypomania, the sufferer will bec dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod me more active and anxious. They tend to become more talkative, sleep a lo cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin t less, take a lot of chances that are out of the norm, and many times ten tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen to be in love with the world. Because of the constant changes in their m 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 ods, people who are close to sufferers of bipolar disorder find them extre ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust mely difficult to deal with. This is also the case when friends or family y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products embers attempt to communicate with them. Because of the constant hospitali . 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 zation needed in order to treat people with manic depression, sufferers of elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip this disorder find it very difficult to function in their daily 9 – 5 jobs 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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