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In our continuing series on eating disorders, this article will focus on Anorexia Nervosa.

Anorexia Nervosa is a very serious eating disorder which can be

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

potentially life threatening. It's main characteristic is self starvation and excessive weight loss.

Anorexia Nervosa has four main symptoms and they ar

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

Examples of combination products may in

as follows:

1. A strong resistance to maintaining a person's body weight at or above what would be considered a normal minimum body weight for that pers

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

n's age, weight and height.

2. A very strong and intense fear of getting fat or being overweight even though to all appearances the person is at a normal

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

or even below normal weight.

3. A strong disturbance by the shape of the person's body. An obsession with achieving a certain look that, though to all

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

Combination pro

ormal appearances, is thin and frail, to the person suffering from this disease looks perfectly normal.

4. A sudden loss of the menstrual cycle in women

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

ho are past the age of puberty and in girls who have yet to reach puberty, the cycle never begins.

It is important that to have the best chance of success

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

fully treating a person with Anorexia Nervosa that the disease be diagnosed early and treatment begin immediately.

There are many warning signs that someo

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

e is suffering from this disease. They are as follows:

a. A sudden and dramatic loss of weight in a very short period of time.

b. An obsession with co

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

nting calories, grams, fat content and a number of other things associated with the food the person eats, reaching the point where they keep daily charts o

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

calorie intake to make sure they don't go above a certain level.

c. A gradual elimination of certain food groups that the person believes to be fattenin

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

Following aspects would a

g such as sweets and eventually reaching the point of eliminating essential foods that contain carbohydrates. Eventually there is very little food the per

dd to the challenges in developing combination products:

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

on will eat.

d. A person suffering from Anorexia Nervosa will often make comments about how fat they are even though it is apparent that they are in no w

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

y overweight. This is usually one of the earliest warning signs.

e. The person may be very hungry and in need of food intake but will deny that they are

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

hungry at all.

f. The person will start to develop odd food rituals such as eating foods in a particular order and arranging the foods in a certain way

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

n the plate. The person will also begin to excessively chew their food in the hopes that more will be digested and less will turn to fat.

g. The person

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

Professional from academic institutions, pharmaceutical industries, health care indust

ill start to make excuses for missing meals such as, homework, tired or just not hungry. They will do anything to avoid eating.

h. The person will often

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

begin a rigid exercise routine regardless of weather, fatigue, illness or even injury. The person will push themselves to any length to get their exercis

.

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

in. This in itself can cause great harm if the person is out of shape.

i. A person suffering from this disease will withdraw from friends and activitie

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

Companies that provide selfless information through particip

. They will eventually become totally reclusive.

In our next article we will cover some statistics of Anorexia Nervosa and some statistics of the disease

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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