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If you think lack of sleep only gets you uncontrollable yawns and bags under your eyes, take note, it may be more costly to your health t

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

han you think!

A study done by Sleep Heart Health has found more evidence of increased diabetic conditions related to lack of sleep. But

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

Examples of combination products may in

it doesn’t stop there; it also shows evidence of the same conditions with too much sleep.

These findings come from a study where 722 men

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

and 764 women, aged 53 to 93 years enrolled in the study. Working with a controlled sleep time of 7 - 8 hours a night and ruling out oth

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

r potential issues such as sleep apnea, insomnia, obesity, sex, age and race. The study shows a strong link between Type 2 Diabetes, impa

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

Combination pro

red glucose tolerance and amount of sleep.

• In those who slept 5 hours or less a night, Diabetes was 2.5 times more common.
• In t

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

hose who slept 6 hours a night, Diabetes was 66% more common.
• In those who slept 9 or more hours a night, Diabetes was 79% more co

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

mon.

Over the past 30 years or so the usual sleep per night has declined for adults aged 40 to 79 years of age. Near the end of the 50’s

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

8 hours a night was the norm with less than 15% reported sleeping less than 7 hours a night. Once we turned the new millennium, the usua

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

l sleep times dropped to 7 hours a night and approximately 35% of targeted adults reported sleeping less than 7 hours a night.

Although

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

nsomnia plays some part in this equation, probably brought on by other sleep influences like kids awake at night or tossing and turning o

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

Following aspects would a

the old mattress. It’s amazing to see that the majority of sleep deprivation is voluntary. With 43% of adults polled saying they spend m

dd to the challenges in developing combination products:

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

ore time than they should to stay up either watching television or using the Internet, the other whopper being 45% reporting staying up l

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

ter or getting up earlier to get more work done.

When most people see these numbers and results they think that you would have to do thi

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

over a lifetime to have these adverse affects. But the study also shows results of impaired glucose tolerance in healthy young adults wh

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

en sleep was restricted to 4 hours a night for 6 straight nights, 6 nights, that certainly isn’t a lifetime! Keep in mind that Diabetes c

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

Professional from academic institutions, pharmaceutical industries, health care indust

rries a high risk of cardiovascular-related problems which can severely shorten your lifespan.

“This is one additional piece of informat

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

on bolstering the common recommendation for sleeping 7 to 8 hours a night,” says, Boston University’s Dr. Daniel Gottlieb, study co-autho

.

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

r.

I can deal with the bags under the eyes and the fly catching yawns but life’s blowing by as it is and I certainly want to be around w

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

Companies that provide selfless information through particip

en my 6 and 8 year old kids graduate, at least. I realize that you can’t always get the right amount of sleep but I know I can always try

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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