Advice Pool - Health and Fitness

With the ever-increasing number of Americans with obesity problems, cases of anorexia are also noticeably on the rise. Technically, anorexia nervosa (or anorexia) is an eating disorder that

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

generally afflicts teenage girls and young women. An estimated 0.5 to 3.7% of all American females suffer from this condition at least once in their lives.

Anorexics commonly have extreme

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

Examples of combination products may in

y distorted senses of self-image that they think of themselves as overweight even when they are already dangerously thin.

Although anorexia may seem like a preoccupation over food and weigh

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

control, there is more to it than just the issue of food. Most anorexics use food to cope up with their emotional problems and are craving to exert some control over their lives. They fee

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

l that if they can't control what is happening in their lives or in their environment, they can at least exert control over their food intake and their weight.

Most anorexics are perfection

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

Combination pro

sts. They have very high standards and often feel the need to prove themselves. They feel that in exerting strict control over their diets they can achieve their projected state of perfect

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

on. Those afflicted with this condition often relate their worth with how thin they have become.

There are anorexics who put severe restrictions on their food intake in order to achieve th

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

eir desired "perfect" state of emaciation while there are also those who go on a binge/purge cycle. Anorexics also tend to exercise excessively to further lose weight.

Aside from drastic w

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

ight loss, there are several physical and emotional signs indicating the onset of the disorder.

Among the more evident physical signs are noticeable thinness, brittle nails, thinning and/or

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

falling hair, appearance of fine downy body hairs ("lanugo"), drying of the skin and/or dehydration and the intolerance of cold. Anorexics may likewise have abnormal blood counts, frequent

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

izzy spells or even fainting episodes, miss regular monthly periods, are usually constipated, have low blood pressure and irregular heart rhythms. They also tire very easily and may eventua

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

Following aspects would a

lly develop osteoporosis.

Anorexics tend to develop certain emotional and behavioral characteristics, which may indicate the inception of the disorder. They may make frequent excuses to av

dd to the challenges in developing combination products:

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

id eating at meal times and usually deny that they feel hungry. They exercise to the point of exhaustion and have difficulty in concentrating. They often have flat moods or display a total

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

lack of emotion. Anorexics also exhibit an unusual preoccupation with food. They make sure that they only eat "healthy" foods, weigh their foods and constantly count calories.

Apparently,

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

these signs and symptoms are not readily noticeable until the more advanced stages of the disorder are reached. Anorexics often do their best to hide the changes in their appearances and t

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

eir eating behaviors.

So, if you are worried about a loved one or someone in your family, be wary of the following warning signs:

. Person frequently skip meals and make excuses for n

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

Professional from academic institutions, pharmaceutical industries, health care indust

t eating (e.g. already ate earlier, not feeling well, etc.).
. Develops an obsession with "healthy" foods and recipes (prefers to eat only low calorie and low fat foods).
. Dev

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

elops unusual eating habits (cuts food into very small pieces, picks at food, moves food around the plate without eating it, spits food after chewing, carefully weighs and portions food). .

.

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

Checks weight repeatedly within the day.
. Wears loose and baggy clothes and/or layered clothing.
. Constantly complains about getting fat and gaining weight.

If someon

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

Companies that provide selfless information through particip

you know exhibits these warning signs, urge him or her to talk to a doctor. Remember that early detection and diagnosis is necessary to increase the chances of recovery from this condition

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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