E-Articles - Health and Fitness

If you’re having a lazy or busy day and you know you’re just not going to ge

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

t to the gym, is there any benefit to putting in a 5 or 10 minute workout at

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

Examples of combination products may in

home?

The answer is yes! Any amount of exercise is better than nothing. Ev

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

en 5 minutes. Recent research is beginning to show that the benefits of exer

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

ise take effect even if the workouts themselves are very short. Even 5 minut

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

Combination pro

es is enough to get your heart rate up, get blood moving, increase oxygen de

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

livery to your muscles and just wake you up! Some research even shows multip

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 short term workouts have similar benefits to longer workouts. An interes

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

ting study compared the effects of three 10 minute workouts to one 30 minute

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

workout. The resulting benefits on the cardiovascular system were the same.

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

This means you can fit a workout into your day in small chunks if you have t

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

Following aspects would a

o. Even as small as 1o minutes at a time! Even if you feel totally pressed

dd to the challenges in developing combination products:

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

for time you can start to make a difference with small steps.

Look at it th

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

is way. Each day we will engage in some level of activity, whether it be a 1

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

k run, a game of volleyball, sitting at a desk, or walking to the fridge fr

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

om the couch. Each scenario is a different level of activity, we are simply

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

Professional from academic institutions, pharmaceutical industries, health care indust

trained to think of specific activities as workouts and define them as benef

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

cial for us.

I wouldn’t say that a 5 or 10 minute workout is ideal, but if

.

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

30 minutes in a row is just not going to happen for you, then even 5 or 10 m

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

Companies that provide selfless information through particip

inutes is worth it.

Remember, every little bit counts, no matter how little

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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