E-Articles - Health and Fitness

One of my college professors often used to make these comments:

Take your breakfast alone; share your lunch w

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

ith someone; offer your dinner to your enemy. I once replied back that the kind of food they served in our col

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

Examples of combination products may in

lege canteen, all the three were to be offered to enemies only. Jokes apart,the common belief and habit for mo

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

st of us to shed extra weight is to starve, depriving nutrition and energy to the body for its activities. In

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

any case, starvation is not the salvation for permanent weight loss. Sooner or later when we get bored, we ret

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

Combination pro

urn back to our sedentary life style, without being aware of the health hazards of being obese.

Obesity is a

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

trojan horse. It brings a battalion of ailments which are most detrimental to our health. To name a few, follo

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

ing are the complications that could arise out being obese.

1. Hypertension

2. Diabetes (Type-2)

3. coronar

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

y heart disease

4. Stroke

5. Gallbladder disease

6. osteoarthritis

7. asthma

8. sleep apnea and respirato

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

ry problems

9. some cancers ( endometrial, breast and colon )

10. High levels of cholosterol

This is an une

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

nding list, where each of the above ailments are capable of creating other complications, where no medication

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

Following aspects would a

without side effect, could be comfortably used. Prevention is the best cure for obesity. How to achieve this?

dd to the challenges in developing combination products:

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

My friend, who was obese, went to the doctor. Doctor smiled at my friend, since he was known to both of us. H

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

e said to my friend that it was very simple to lose weight! My friend became very interested and asked him to

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

uggest the way. Doctor replied that my friend has to only shake his head from left to right, maybe 10 times 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

day, and he was sure to lose weight! My friend became very curious. What is the idea ? he enquired. Doctor cal

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

Professional from academic institutions, pharmaceutical industries, health care indust

mly replied, "whenever anyone offers you something to eat, shake your head from left to right." Simple, isn't

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

it? It is simple, but it requires discipline, which is not simple. But then, habit makes discipline. Avoiding

.

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

junk food and fast food must be done with a discipline.

Besides, exercise is the best option to increase musc

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

Companies that provide selfless information through particip

ular mass and reduce fat. It also increases the metabolic rate and ensures high level of energy and enthusiasm

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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