Advice Pool - Health and Fitness

Let’s face it…exercise is a pain in the you know what. Who has time for exercise in today’s world. It is tough enough to g

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

et everything you need accomplished. We all know we NEED to exercise more than we do, but it is just tough to get around to

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

Examples of combination products may in

doing it. Here is the key. We need to look at exercise not as luxury, but as a required task. We eat and drink each day

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

ecause it is necessary for our survival. Well, it is time we put our health in that category. We only live once (as far as

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

we know), and the length and quality of our lives depends on how we treat our bodies. If we can look at exercise as a nece

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

Combination pro

sity, than we can create our daily routine to include it. Exercise machines are an easy way to accomplish this in just 20 m

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

inutes a day.

I know you have made the excuse that you don’t have the time to exercise. Look, I have used that same excuse

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

for years. Despite the fact that there is a gym nearby, I still used the excuse. Then, my wife (who is avid workout enthus

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

iast) bought an elliptical machine and put it in the bedroom. For those that are unfamiliar, an Elliptical machine is a com

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

ination of a stair climber, and a treadmill. It is a very low impact workout. Well…she placed the machine in front of the

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

TV. Now…instead of parking myself on the couch for whatever show I am going to watch…I have spend at least 20 minutes on th

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

Following aspects would a

e Elliptical machine watching the same show. It takes the whole, “Exercise is boring” excuse out of the equation. Now I kn

dd to the challenges in developing combination products:

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

w not everyone can afford to buy a machine (although they are not as expensive as you might think...and used equipment is a

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

great way to go as well!), but there are gyms all over the place these days, that charge a reasonable fee. And let’s be hon

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

st with ourselves in regards to saying we can’t afford it. Is this really true? Do we not waste money on things all the tim

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

e? Surely we can forgo some of the things we spend money on in order to be able invest in our health.

There are many diffe

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

Professional from academic institutions, pharmaceutical industries, health care indust

ent types of exercise machines to choose from. Whether you are looking for a treadmill, rowing machine, ab lounge machine,

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

elliptical machine, or countless others…there is the right machine, or machines, for you. The purpose of this article is to

.

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

implore you to make exercise part of you daily life! Your body, and you family, will be the better for it. Once you make t

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

Companies that provide selfless information through particip

his part of your day, it will become habit. And how nice will it be to have a habit that makes you feel good about yourself

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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