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Morbid obesity is a frightening term and it is a condition which could spell a death sentence, but it doesn’t have to have such drastic results. If you or someone in your

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

family has been diagnosed as morbidly obese, it can come as a terrible shock. Morbid obesity is a term which is usually reserved for someone with a body mass index of over

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

Examples of combination products may in

40, in other words weighing twice the ideal weight. However, that shock diagnosis can also be interpreted as a wake up call and can trigger a positive reaction after year

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

s of ignoring the problem. And the fact that serve around 3 million adults in America are morbidly obese should serve as a warning to anyone who is considerably overweight

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

, encouraging them to take action to prevent their ending up in this category.

First of all, it is important to understand the problems related to morbid obesity. Anyone

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

Combination pro

suffering from this condition will know that it severely restricts lifestyle, making day to day activities which most of us take for granted either difficult or impossible

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

. If the situation is allowed to become worse, sufferers can become so incapacitated that they can no longer leave the house, which in most cases means they are unable to

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

work. Being stuck at home is not good for self confidence and of course the person’s ability to exercise is also greatly reduced, which makes weight loss even more difficu

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

lt. In addition, there are significant health risks associated with morbid obesity. These include diabetes, which can have series side effects, such as blindness and kidne

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

y failure, heart disease, many types of cancer, stroke and sleep apnea. There are more, but that list should be enough to motivate most people to take action, and if it do

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

esn’t, perhaps the fact that seriously obese people are twice as likely to die young as the rest of the population will make a difference.

The quickest way to lose a larg

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

Following aspects would a

e amount of weight is by gastric surgery, but this is a drastic solution and can have adverse side effects. Any form of surgery carries certain risks, and those risks are

dd to the challenges in developing combination products:

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

greatly increased the more overweight the patient, in fact, the mortality rate is relatively high at around 3-5%. Gastric surgery is therefore usually only considered as a

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

last resort, when other options have been unsuccessful.

Diet and exercise are the preferred options for weight loss and anyone who is morbidly obese should make sure tha

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

t they have the advice and support of professionals in both these areas, and they should also be prepared to make major lifestyle changes. Medical help will be needed if

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

a healthy weight is to be achieved and so anyone who is morbidly obese much work with a doctor, who will refer them to dieticians and other relevant professionals.

If you

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

Professional from academic institutions, pharmaceutical industries, health care indust

have children and are obese yourself, the likelihood of your kids growing up to be severely overweight is increased. This may have some basis in genetics, but don’t use t

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

hat as an excuse, unless it has been proved medically. If you have children or grandchildren this should give you the incentive to lose weight, so that you can spend more

.

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

time with them and to encourage them to develop healthy eating habits.

Morbid obesity is a major health problem and needs to be taken seriously. It is not something which

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

Companies that provide selfless information through particip

an individual should tackle alone, but which requires medical advice, the support of friends and family and a commitment to making lifelong change.

© Waller Jamison 2007

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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