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Self induced emotional eating disorder characterized by persistent loss of appetite is called anorexia. Excessive consciousness toward weight loss, counti

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

ng calories and excessive exercises can lead to a severe emotional eating disorder called anorexia.

Some diagnosing signs and symptoms of anorexia are:

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

Examples of combination products may in

> - Excessive consideration to become thinner and thinner.
- Misperception of body shape and weight.
- Fear of body weight gain and fat.

Per

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

sons suffering from anorexia do not feel the danger of denying food. Calories, food, weight, fat grams and weight management are the most important factor

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

of a person’s life with anorexia.

What are the signs and symptoms of anorexia?
People who have anorexia love to live in secrecy so that no one can

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

Combination pro

know about their condition. In this situation, it is very hard for doctors to properly diagnose them and treat them.
Some of the common symptoms of

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

norexia are:
• Dramatic weight loss.
• Excessive consciousness about figure and body image.
• Regular skipping of meals.
• Mostly e

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

at selective foods, which are low in fat and calories.
• Good cook but try to avoid meal.
• Usually wear loose clothes to hide thinness.

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

Strong exercise regimen.
• Skip social gatherings, especially dinner or lunch parties.
• In males decreased libido and in females irregular m

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

enstrual periods.

What are the types of anorexia?

Basically there are two types of anorexia.

Restricting Anorexia (Classic Anorexia) - Person with rest

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

icting anorexia eats very little and loses weight due to excessive exercise and self or induced starvation. They possess less calories to perform body fun

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

Following aspects would a

ctions.

Purging Anorexia or Binge-Eating – Person with binge eating will perform self induced vomiting, diuretics, enemas and misuse of laxatives. Person

dd to the challenges in developing combination products:

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

shows signs of both bulimia and anorexia. More than 50% of the persons having anorexia might also get into bulimia.

What are the effects of anorexia?

Ph

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

ysical effects of anorexia

Some of the physical effects of anorexia are:
• Decreased immunity
• Hair loss
• Less resistance for heat

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

• Sleeplessness
• Chronic dehydration, which can even cause kidney failure
• Weakness and Fatigue

In some rare cases you will notice the sympt

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

oms of low heart rate, low body temperature, heart trouble, low blood pressure, poor circulation, chronic anemia and even death.

Behavioral and Emotional

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

Professional from academic institutions, pharmaceutical industries, health care indust

effects of anorexia

During anorexia the following emotional and behavioral effects can occur:
• Depression
• Irritability
• Bad memory a

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

nd difficulty in concentrating
• Isolation from friends and family
• Emotional regression
• Feelings of guilt
• In some severe cases

.

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

one can search a solution in the form of alcohol and drugs to handle negative outlook

Anorexia Nervosa is a disease that one has to take very seriously.

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

Companies that provide selfless information through particip

Often the symptoms show and become obvious for parents and doctors too late. This makes the treatment harder and in the worst case treatment will not work

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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