Your Space - Health and Fitness

While counseling a patient recently, we needed to find a way for him to drop 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

significant amount of weight. There were several circumstances that kept him fr

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

Examples of combination products may in

m doing any weight training or high-intensity exercise (brain aneurysm, disloca

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

ed shoulder, extreme obesity).

I told him that the best thing he could be doin

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

g was walking. He complained that he had osteoporosis. I told him that the bes

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

Combination pro

thing he could do to fight osteoporosis: WALK!

He said that his hips hurt him

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

when he stood for a long time. I told him the best thing he could do to allevia

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

te that: WALK!

He complained that walking wasn't fun because he had to stop an

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

sit often, because he was too tired. I told him the best way to overcome that:

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

WALK!

Fortunately, his cholesterol wasn't an issue, but if it had been, and I

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

anted him to find something that would increase his HDL (good cholesterol), any

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

Following aspects would a

guesses what I would have told him to do? It's so simple, yet has so many hea

dd to the challenges in developing combination products:

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

th benefits.

Beyond the results that I mentioned, a walking program can help y

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

u burn calories, tone the legs, increase endurance, release endorphins which ca

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

n decrease stress and improve mood, increase flexibility, increase ability to u

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

ilize oxygen-making breathing easier.

Not too bad for something you can do pre

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

Professional from academic institutions, pharmaceutical industries, health care indust

ty much anywhere and for no cost!

Make it a point to walk everyday, even if fo

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

r 30 minutes. Go at lunch. Go when you get home. Take your kids with you and wa

.

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

k to a park or school. With fewer families sitting down at the dinner table and

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

Companies that provide selfless information through particip

eating together, let the walk be your time to catch-up on what went on that day

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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