E-Articles - Health and Fitness

The cabbie who drove me from the airport to the hotel on my last business trip probably weighed 400 pounds. We ma

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

de small talk during the trip. He told me he was hoping to leave Nevada soon and move to Oregon. But, he said, i

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

Examples of combination products may in

t was tough getting the time and resources to make the move.

He works 12 hours days, six days a week. The cab co

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

mpany deducts chunks of his pay for their share of his revenues and to cover his health insurance premium and a t

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

ax on his tips. His take home pay is $500 every two week pay period.

As we started talking about his health insu

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

Combination pro

rance, the conversation naturally drifted to health. He is prediabetic, he told me, and his brother is a type 2 d

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

iabetic who has already had some toes amputated. He knows he is facing the same future if he doesn't lose weight,

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

but how can he do it?

When you drive a cab 12 hours a day, you often eat on the run. That means fast food, high

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

fat, and lots of calories. Also, how do you fit in exercise? Should he try to walk before the 12 hour shift or,

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

perhaps, go out in the middle of the night when his shift is over?

I found myself wondering what I would do if I

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

were his doctor. Of course, I would recommend he lose weight, alot of it. And, I would tell him to get moderate

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

Following aspects would a

to vigorous exercise 30 to 60 minutes a day. I would prescribe any needed medications.

Chances are, in my 15 min

dd to the challenges in developing combination products:

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

ute office visit, I wouldn't have learned about the challenges presented by his daily schedule. I wouldn't unders

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

tand that my recommendations were unlikely to be followed -- not because he wouldn't, but rather because he couldn

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

't.

If something doesn't change, his prediabetes will most likely become diabetes. He will probably have a heart

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

attack or stroke or maybe, like his brother, he will end up with toes or feet amputated -- all potentially preven

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

Professional from academic institutions, pharmaceutical industries, health care indust

table if he could change his lifestyle.

At the end of the ride, all I could think of to say was that he needed to

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

get a new job -- one that is less stressful and would allow him to exercise and eat better. But I knew this too

.

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

would be a daunting task given the long hours he already works and the meagerness of his financial resources.

I k

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

Companies that provide selfless information through particip

eep mulling over his story and wondering, how could you help this man? I haven't come up with an answer. Can you

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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Organisations or employers need to realize that if they want sustainable improvements in employee productivity, it will NOT happen through repeated resort to salary increases – or promotions. Even employee training does not always yield desired long term results. Some companies send employees on routine training, but neglect to investigate what an individual employee’s REAL developmental need is - often resulting in the training expenses and other resources being wasted. What is needed, is for the employee to be empowered - with the appropriate exposure and resources - to achieve his/her maximum career potential. In this article, I describe some relatively little used, but tested and proven strategies, that can be successfully applied within any organisation, to achieve sustainable improvements in employee productivity.

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