E-Articles - Health and Fitness

Anorexia is an eating disorder that develops when someone stops eating enough food for adequate nutrition. It can happen slowly, over several months o

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

r even years, as when some people grow older or develop an underlying disease like cancer. As their appetite dwindles, they may stop eating altogether

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

Examples of combination products may in

or gradually eat less and less. Without taking in enough calories or nutrients, a person can get sick or become weak. Any other health condition that

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

develops during this time can then further compromise that person’s health.

Another type of anorexia is based on personal self-image. People who are

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

trying to lose weight sometimes take extreme measures by reducing the amount of food they eat and eating much less frequently. While it can be easy to

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

Combination pro

lose several pounds each week in this way, such dramatic weight loss can lead to unhealthy consequences, including heart arrhythmias, weakness, dehydr

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

ation, loss of concentration, and nutritional imbalances, among others. If left undiagnosed and untreated, some of these results can be fatal.

If you

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

suspect someone you care about has anorexia, here are some of the possible symptoms that may indicate the presence of this situation.

1. The person

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

ay eat little or nothing for many meals. Watch to see how much food is placed on the person’s plate, whether she eats it all, and if she has second he

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

lpings. If she picks at her food, spits some bites into her napkin, or leaves some on her plate, this could signal that she isn’t getting much nutriti

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

n, especially if it happens frequently. She may sip water instead or poke at her food instead of taking regular bites, chewing, and swallowing.

2. Th

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

Following aspects would a

e person may binge and purge. You might see the person stuffing her face with regular or high-calorie foods, and then disappearing into the bathroom s

dd to the challenges in developing combination products:

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

oon after eating. Excessive eating followed by fasting, or binging following by prolonged bathroom visits may be signs that the person is not processi

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

g food correctly.

3. The person may use diet aids or medications to slow eating. If you have access to her medicine chest, or feel comfortable enough

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

asking, you can find out if the person is taking diuretics to make her urinate more frequently and eliminate extra water for temporary weight loss. A

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

anorexic also may be taking appetite suppressants that cause her to feel less hungry and to eat less. She also might have medication to cause frequen

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

Professional from academic institutions, pharmaceutical industries, health care indust

t bowel movements, or even take enemas fairly often. This, however, may cause the intestines to become sluggish and stop working much on their own.

4

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

. The person might show signs of moodiness, fatigue, or depression. These, however, also may represent other conditions as well, so urge the person to

.

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

see the doctor if you’re not sure anorexia is the cause.

If someone under your supervision shows symptoms like these, take her or him to the doctor.

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

Companies that provide selfless information through particip

If the person is an independent adult, make yourself available as a confidante, and when opportunities arise, be ready to advise a medical examination

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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I have been doing a lot of research on regulatory bodies, including the FTC. Recently in the FTC’s report on franchising 432-pages I noticed a some discrepancies, which were contrary to my personal knowledge and observation of the agency; specifically the franchising division.

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