Summary - Health and Fitness

Obese in simple terms means an excess of fat, usually in the absence of underlying disease, except in a few cases where hormonal disturban

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

ce can be held responsible for it. Life insurance companies have defined obesity in terms of risk to life from the available data of heig

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

Examples of combination products may in

t and weight. There are various methods to assess the amount of fat in the body which ascertains the degree of obesity. Skin fold thickn

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

ess measured by calipers, body mass index, waist/hip ratios, in fact there are standard tables available but body mass index and waist hip

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

ratios are mostly considered. The ratio of weight in kilograms divided by square of height in meters is usually taken into consideration

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

Combination pro

as a quick method of calculation and this ascertains the body mass index and thereby relative risk involved. A BMI of 25 is taken as the

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

pper limit of normal, 25-30-low, 30-35 moderate, 35-40 high and above 40 is very high risk zone.

Obesity could also be a metabolic defect

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

as a calorie intake of 4700 to 8500 calories in different individuals can lead to a gain of 1 kg weight. Various studies show that ATP-a

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

e activity may be low in obese people and lead to a condition where energy consumption is lower and added to surplus calories results in t

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

he deposit of adipose tissue. Eating disorders, wherein hunger and satiety levels do not match, binge eating on emotional highs or lows,

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

enetic predisposition, or endocrine obesity where hypoactivty of the thyroid gland may lead to abnormal weight gain. Not a very healthy s

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

Following aspects would a

lution is the use of medicines which suppress appetite.

The consequences of obesity can be medical problems such as early occurrence of c

dd to the challenges in developing combination products:

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

ardiovascular diseases where fat deposition in the blood vessels leads to atherosclerosis, hypertension, diabetes, pulmonary disorders, ga

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

l bladder stones and sometimes musculo-skeletal problems especially osteoarthritis of the knees. Hypoventilation in obese people may even

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

result in sudden deaths during sleep. Obesity can be managed by diet counseling, behavior therapy and regulated exercise and in some cas

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

s with drugs which suppress appetite by attacking the hypothalamus in the brain. However, the drawback is a quickly following rebound af

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

Professional from academic institutions, pharmaceutical industries, health care indust

ter withdrawing the drug. In cases of morbid obesity procedures like liposuction and surgery like jejuno-ilear bypass are not free from r

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

sk and the latter is only resorted to save life which has its own complications.

A healthy lifestyle with regular exercise from childhood

.

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

onwards can lead to similar adult behavior. Skipping breakfast can affect your concentration at work or school and by mid-morning you te

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

Companies that provide selfless information through particip

d to substitute it with less nutritious morning snacks. You are what you eat so try to follow the golden rules from the beginning of life

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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Summary - Obesity - A Few Causes And Treatments

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