E-Articles - Health and Fitness

Obesity rates are escalating. Statistic cause major alarm as the percentage of overweight and obese children and adolescents

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

has doubled in the last two decades. Can it be controlled?

Statistics may not be, but indirectly, individual persons can.

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

Examples of combination products may in

ontrol on obesity could be answered by personal conviction – a devotion to one’s wellbeing. Yet how?

Statistics also show t

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

hat most people are unaware of the basic nutritional needs and limitations required for their consumption. This may be the k

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

y.

Control on obesity is possible by controlling one’s eating habits. Only about 2,000 calories a day should be consumed by

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

Combination pro

women and 2,500 for men. Eating beyond these amounts would oblige them to have an additional activity control on obesity. S

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

that’s it – don’t eat beyond what your body can burn off, otherwise pump up your muscles an extra mile.

Standards recogniz

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

e people who have sedentary lifestyles. There’s nothing wrong with being deskbound. What’s wrong is when their energy intake

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

is not balanced (greater) with their activity output. On the other hand, people with very active lifestyles like athletes 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

manual laborers require more caloric intake. And compared to women who are neither pregnant nor nursing, pregnant and/or nu

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

sing mothers need more calories per day than usual. If you’re not under these categories then perhaps you should start count

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

Following aspects would a

ng your spoonfuls, or your reps. Remember that excess protein or carbohydrate intake is converted to fat for storage. And on

dd to the challenges in developing combination products:

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

e pound of fat represents about 3,500 excess calories. So watch the scale – an extra pound could mean multiple tons of immed

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

ate control on obesity, before anything else slips off hand.

Once you get a control on your caloric balance then you may no

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

longer have to engage in a dubious control on obesity. To approximately determine your caloric needs, you can compute for y

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

ur Basal Metabolic Rate or BMR. More serious control on obesity deals with BMI, but in the case of a preventive control on o

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

Professional from academic institutions, pharmaceutical industries, health care indust

besity, you can easily compute for your BMR.

The BMR determines the number of calories that your body needs in order to mai

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

tain its basic functions as well as to sustain or regulate your current weight (or calorie-intake). To compute for your BMR,

.

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

just take your current weight in pounds and multiply it by 10. If you are on a standard activity level and weigh 180-lbs. t

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

Companies that provide selfless information through particip

en you only need 1,800 calories a day! – There’s absolutely no need to worry that your body isn’t getting enough ‘nutrition’

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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