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There are three main types of eating disorder; these are Anorexia Nervosa, Bulimia Nervosa and Binge Eat

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

ing Disorder. The term eating disorder is used to describe any eating patterns that are obsessive and lo

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

Examples of combination products may in

g lasting. In the last 20 to 30 years or so there has been a marked increase in the amount of people tro

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

bled by these disorders. Let’s have a brief look at the three variants.

Anorexia nervosa

Anorexia is a

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

eating disorder where individuals starve themselves of food, because they have an obsessive longing to

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

Combination pro

e thin. This disorder tends to affect mainly teenage girls, but can also affect men, and it is serious a

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

d sometimes even fatal. About half of the people with anorexia who have hospital treatment still struggl

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

with the disorder and have symptoms for a long time afterwards. One trait of sufferers seems to be a la

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

k of self-esteem.

Bulimia nervosa,

Bulimia nervosa, usually shortened to bulimia, is an eating disorde

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

where individuals have a binge-eating session; this is usually then followed by them making themselves

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

ick. This self-induced vomiting is because of feelings of guilt at having eaten so much. People with bul

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

Following aspects would a

mia tend to suffer from an unnatural preoccupation with their own body, and as with anorexic patients th

dd to the challenges in developing combination products:

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

y have a fear of gaining weight. Individuals who suffer with bulimia will devour huge quantities of food

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

in an attempt to reduce stress, and help them deal with feelings of anxiety.

Binge eating disorder

Bin

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

e eating disorder involves bouts of overeating high calorie foods on a regular basis, but unlike bulimia

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

sufferers, they don’t make themselves vomit. People with this disorder not surprisingly, are usually ove

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

Professional from academic institutions, pharmaceutical industries, health care indust

weight. This disorder was first recognized about 45 years ago; but it is only in recent times that it ha

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

been seen as a widespread problem. Studies have shown that binge eating disorder seems to run in famili

.

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

s, so it looks like there is a genetic link.

The rather worrying news is that the big three eating diso

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

Companies that provide selfless information through particip

ders - anorexia, bulimia, and binge eating disorder, are reported to be on the rise all around the world

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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