E-Articles - Health and Fitness

I’m sure you have asked your friends or even trainers, do I need to wear a

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

weight lifting belt while weight training? Half of them probably said yes

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

Examples of combination products may in

while the other half said no. So where does that leave you? Maybe you sho

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

uld have asked them, when should weight lifting belts be worn?

Based on r

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

search from Stuart McGill who is a professor of spine biomechanics at the

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

Combination pro

University of Waterloo in Ontario Canada, it all depends on the type of tr

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

ining you perform. McGill does not recommend weight lifting belts for heal

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

thy individuals. His exception is for extreme bodybuilders because a weigh

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

lifting belt will help increase stability.

Below is a list of advantages

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

and disadvantages of wearing weight lifting belts: Advantages - They hel

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

support your spine

- They help decrease the chance of lower back injury

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

Following aspects would a

- Give people confidence they may not have had prior to training without a

dd to the challenges in developing combination products:

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

belt

Disadvantages - Some people may cover up an injury with the belt

-

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

Increase of blood pressure depending on how tight you make it

- They may

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

cause a slight change in your lifting style, which may cause injury

I am

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

firm believer in wearing weight lifting belts. I started with one when I

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

Professional from academic institutions, pharmaceutical industries, health care indust

was younger and have been wearing one ever since. I guess it is like a sec

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

rity blanket for me. It also makes me feel “BIG” and gives me confidence.

.

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

My thought is, if a weight lifting belt makes you feel good and it psychol

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

Companies that provide selfless information through particip

gically helps you to perform better in the gym, then by all means, wear it

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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