Advice Pool - Health and Fitness

Eating disorders, foremost among them Anorexia Nervosa, afflict upwards of 8 out of every 100,000 people each year; 40% of this statistic is composed of adolescent females between the ages of 15 a

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

nd 19.

An eating disorder is defined as "a complex compulsion to eat in a way which disturbs physical, mental and psychological health". This compulsion can have a multitude of different effects

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

Examples of combination products may in

depending upon the particular person who feels it. The victim may be compelled to eat more than is healthy, or far less; the victim may eat vast quantities of food and then, through forced vomit

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

ing or overuse of laxatives, cause the food to evacuate the body without being digested. This is partly what makes eating disorders so hard to diagnose and treat - there is no specific set of sym

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

ptoms and, due to this, the practitioner in question may need a large amount of time to formulate a proper mode of treatment.

Eating disorders are also the topic of a latter-day societal taboo in

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

Combination pro

modern life - due to images of modern body image perpetrated by the media, there is scant difference between "a perfect body" and a "dangerously underweight body"; and, assuming that the body in

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

question was deliberately being maintained, automatically assuming that there is an eating disorder in effect may be perceived as offensive. For this reason, the topic of eating disorders, as wel

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

l as attempts by the friends and family of a victim to seek help for that victim, is seen as an issue where it is easier to avoid a minor inconvenience while risking the victim's health than to ri

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

sk embarrassment if there is a problem.

In the public consciousness, one eating disorder is foremost: Anorexia. To aid discussion of eating disorders, a brief discussion of this particular eatin

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

g disorder shall be entered into

Anorexia or, as it is more properly known in medical circles, Anorexia Nervosa ("Nervous Anorexia"), affects between 8 and 13 per 100,000 people depending on the

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

demographics of the population being examined. Anorexia is the most commonly known eating disorder to the general public, due to media exposure. Indeed, this exposure causes many people to heap

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

Following aspects would a

all eating disorders, or under-eating disorders, into a single category under the name anorexia. This is both a symptom and cause of more ignorance and misunderstanding faced by people trying to

dd to the challenges in developing combination products:

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

deal with eating disorders - someone with an unrelated eating disorder may be told (by friends and family) to seek treatment designed for anorexia sufferers which will provide no help to them; sim

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

ilarly, someone suffering from Anorexia Nervosa may be told to seek a treatment method which was observed being administered to someone with an unrelated eating disorder.

Anorexia is characterize

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

d by a fierce mental compulsion not to consume food at all, lest this cause the victim to become overweight and a gross distortion of body image, which causes the victim to believe he/she is overw

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

eight no matter what weight they really are. Someone who is perceived by other people as a mere bag of flesh and bones may she him/herself as grossly, morbidly obese and will seek to fix this per

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

Professional from academic institutions, pharmaceutical industries, health care indust

ceived problem by eating yet less. It is not uncommon for chronic untreated cases of anorexia to cause death by starvation to the sufferer.

Due to specific societal conditions, understanding of

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

eating disorders is limited. Many are ignored out of convenience and fear of embarrassment, while some people prone to hypochondria even wish to be seen as afflicted by this terrible disease. Ea

.

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

ting disorders are terrible in this way because they are of the type Nervosa - caused by nervous system reactions and not transmitted as most diseases are by bacteria and viruses. Eating disorder

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

Companies that provide selfless information through particip

s are truly a disease borne of the modern age. Only through education of friends and family, as well as abolition of the senseless taboos associated with them, will eating disorders be conquered.

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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