Summary - Health and Fitness

Everyone wants washboard abs but how exactly do you get them? The answer has not been very clear and many professional f

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

itness trainers disagree about the proper way to achieve that desirable mid section. This causes much confusion amongst

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

Examples of combination products may in

heir clients. “Am I wasting my time doing hours of abdominal work every week?”

For some time now there have been two sc

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

ools of thought – those who believe the only way to see your abs is to focus on shedding whole-body fat levels through d

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

et and aerobic exercise, and those who say that you have to do lots of abdominal exercises to reduce the fat in you mid-

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

Combination pro

ection.

Up until now, many scoffed at the premise of exercise induced spot-fat-reduction. Well the jury is finally in 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

nd it appears that spot-fat reduction is a reality.

While whole body fat reduction is best served by reducing caloric i

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

take and performing aerobic exercise, there is now evidence that the fat that is directly adjacent to the working muscle

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

burns at a higher rate than fat that is adjacent to the resting muscles. It stands to reason, but until now, has not be

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

n proven.

A study published this month by the Department of Medical Physiology at the Panum Institute, University of Co

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

enhagen in Denmark showed that subjects who performed high repetition leg extensions at varying intervals and resistance

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

Following aspects would a

levels for up to two hours with one leg at a time exhibited a higher degree of fat oxidation in area directly adjacent

dd to the challenges in developing combination products:

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

o the working leg muscles.

This increase in fat oxidation was irrespective to exercise duration or intensity. The fat d

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

rectly adjacent to the working muscles burned at a higher rate than the resting muscles. Period.

This increased fat oxi

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

ation was also associated with a higher degree of blood flow to the local area of the working muscles and adjacent fatty

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

tissue. This may enhance the fats ability to be carried away and disposed of by the liver thus increasing the likelihood

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

Professional from academic institutions, pharmaceutical industries, health care indust

that the fat won’t simply be re-deposited elsewhere.

The take away from this study is very clear and should put the de

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

ate over exercise induced spot-fat reduction to rest once and for all. If you want to rid yourself of the fat that cover

.

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

a specific area of your body, such as your abs, you’ll have the greatest success if you focus on exercises that work th

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

Companies that provide selfless information through particip

muscles directly adjacent to the problem area. If you want washboard abs you’ll have to start doing more abdominal work

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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