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Many people are suffering from eating disorders these days. The most common eating disorders are Anorexia Nervosa (anorexia) and Bulimia Nervosa (bulimia). Both are v

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

ery dangerous eating disorders that may even cause death. Eating disorders usually occur on the background of emotional instability, confusion, loneliness, depression

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

Examples of combination products may in

and low-self esteem.

Anorexia Nervosa is characterized by unusual behaviors related to food consumption, the refuse of keeping a body weight appropriate to one’s ph

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

sical build, age and sex, the development of obsessions regarding food and weight and a false perception of one’s body image. People with Anorexia Nervosa are always

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

preoccupied with their physical appearance, carefully weighing their meals and counting the calories they consume. Although people with Anorexia Nervosa sustain const

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

nt efforts to lose weight by following drastic diets and exercising excessively, they are never pleased with their accomplishments, always aiming to lose even more we

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

ight. Persons with Anorexia Nervosa, despite being underweight, may actually see themselves as fat.

There are two kinds of Anorexia Nervosa: the restrictive and the

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

ompulsive kind. People who suffer from Restrictive Anorexia Nervosa usually have a very low body weight. They indulge in acts of self-starvation and also tend to burn

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

the little food they eat through physical exercise, in order to lose weight. Compulsive Anorexia Nervosa, also referred to as Binge and Purge Anorexia, resembles 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

symptoms of Bulimia Nervosa. Bulimia is characterized by the consumption of large amounts of food and then getting rid of it by purging it from the system. Just like

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

in the case of Bulimia Nervosa, Compulsive Anorexia Nervosa implies and alternation in eating habits, people suffering from it fluctuating between periods of scarce e

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

Following aspects would a

ating or abstinence from food and periods of binge-eating and purging.

The persons with this kind of Anorexia Nervosa purge the food out of their bodies by vomiting

dd to the challenges in developing combination products:

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

r by taking laxatives and diuretics. They also tire themselves through long, sustained physical exercise in order to lose weight. Unlike people with Restrictive Anore

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

xia Nervosa, the ones confronted with the second type of disorder aren’t always underweight. People with Binge and Purge Anorexia experience a lot of changes in their

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

body weight. They resemble bulimics in physical appearance and behavior.

Actually, Anorexia Nervosa and Bulimia Nervosa have a lot of things in common and in fact, p

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

eople who suffer from Anorexia Nervosa may later become bulimics.

Anorexia Nervosa, just like other eating disorders causes a lot of harm to people affected by it. A

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

very disturbing fact is that young people, especially adolescents are the most exposed to the development of eating disorders. Both sexes are susceptible to the threa

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

t of Anorexia Nervosa, but particularly girls and young women develop forms of Anorexia Nervosa, due to their constant preoccupation with looks.

The causes of eating

.

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

disorders haven’t yet been determined. It is considered that Anorexia Nervosa is purely a mental condition. However, studies sustain that there are also physical fact

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ors involved in the development of the illness. Also, a disturbing fact reveals the hereditary character of eating disorders like Anorexia Nervosa and Bulimia Nervosa

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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