Useful Articles - Health and Fitness

In this day and age it is becoming increasingly likely that you wont get enough sleep at night. Many people have a hectic lifestyle, juggling a high stress job with family life, and don’t even think about trying to incorporate a social life in there. Every thing is going on so fast these days that no one is ready to rest sinc

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

e they fear if they sleep someone other may go ahead of him. Many have become so intellectual that they are ready to change the rules of nature. They say that sleeping is nothing but waste of time. But those who try to change the rules of almighty have their own troubles.

The rule of the thumb is that the average adult needs

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

Examples of combination products may in

approximately 8 hours of sleep per night. This can vary depending on the person though, some may only need 6 hours and other may need 10. Some people will think they need a lot less sleep than this of course. Margaret Thatcher famously needing only 4 hours' sleep a night during her 11 years as the UK Prime minister. However y

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

u may think you only need a few hours of sleep but this will probably have health consequences on your body.

It is reported that over 40 million Americans suffer from sleep disorders, with 60% of Americans having problems sleeping a few nights a week. Psychologists and other scientists who study the causes of sleep disorder

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

s have shown that such problems can directly or indirectly be tied to abnormalities in the following systems:
· Brain and nervous system
· Cardiovascular system
· Metabolic functions
· Immune system

Furthermore, unhealthy conditions, disorders and diseases can also cause sleep problems, including:

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

Combination pro

· Pathological sleepiness, insomnia and accidents
· Hypertension and elevated cardiovascular risks (MI, stroke)
· Emotional disorders (depression, bipolar disorder)
· Obesity; metabolic syndrome and diabetes
· Alcohol and drug abuse

Groups that are at particular risk for sleep deprivation include nig

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

t shift workers, physicians (average sleep = 6.5 hours a day; residents = 5 hours a day), truck drivers, parents and teenagers. Stress is the number one cause of short-term sleeping difficulties, according to sleep experts. Common triggers include school or job-related pressures, a family or marriage problem and a serious i

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

llness or death in the family. Usually the sleep problem disappears when the stressful situation passes. However, if short-term sleep problems such as insomnia are not managed properly from the beginning, they can persist long after the original stress has passed.

Each year the cost of sleep disorders, sleep deprivation and

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

leepiness, according to the NCSDR, is estimated to be $15.9 million in direct costs and $50 to $100 billion a year in indirect and related costs. And according to the NHSA, falling asleep while driving is responsible for at least 100,000 crashes, 71,000 injuries and 1,550 deaths each year in the United States. Young people in

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

their teens and twenties, who are particularly susceptible to the effects of chronic sleep loss, are involved in more than half of the fall-asleep crashes on the nation's highways each year. Sleep loss also interferes with the learning of young people in our nation's schools, with 60 percent of grade school and high school ch

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

ldren reporting that they are tired during the daytime and 15 percent of them admitting to falling asleep in class. The following are some tips on how to try and get the best nights sleep possible.

1) Go to bed and get up about the same time each night and morning. If at times it becomes late to sleep at night try to recove

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

Following aspects would a

r it by sleeping for some more time in morning. Avoid going early in the bed. Go to bed only after you feel sleepy.

2) Do the exercise regularly in the evening some three to four hours before bed. See that you get at least 30 minutes of sunlight exposure daily. Do yoga, meditation and gym early in the morning. This is will h

dd to the challenges in developing combination products:

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

lp to give energy to work for the whole day. The strained muscles will undoubtedly ask for rest at night.

3) Have a long, warm bath or shower before bedtime. Follow bedtime rituals. Listening to soft music read a book to calm the body. Avoid reading violent news or watching suspense or horror movies that will have brain thin

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

ing about.

4) Have warm milk before bedtime. Have dinner about two hours before sleeping. Have water bottle besides you so that you don’t have to walk up to the water pot.

5) The bedroom area should be silent and as far as television is considered should not be in bedroom. The room should have a comfortable atmosphere. Put

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

curtains where the light is piercing in the room. Change the bed sheets regularly. The room should have proper ventilation. Avoid having illuminated clock in bedroom that makes you anxious and keeps you thinking about time.

6) Avoid sleeping in afternoon. Avoid caffeine and nicotine in all forms after lunchtime. Caffeine in

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

offee, tea, chocolate, colas; other soft drinks should be avoided.

7) If you don’t get sleep withinn 10-15 minutes and feel that you can’t get sleep leave the bedroom. Get on with some book or watch television until you feel drowsy.

8) Some people have pills for sleeping try to reduce it and continue till you get rid of it.

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

Professional from academic institutions, pharmaceutical industries, health care indust

If not controlled it just becomes a habit. Proper care should therefore be taken and physician should be consulted.

9) Recollect all the activities performed during the day. Note down the worries you are facing and possible ways to achieve the solution. This will remove the burden of your shoulders and so you need not think

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

of it as you go to the bed.

10) Main reason for sleep problems is stress. The relief from tensions and anxieties often eliminates sleep problems.

11) Have light meal before bed. Eating heavily can cause adverse effects.

12) Most people you have to travel across the globe through various time zones in such cases they should

.

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

practice the timetable of that country in advance so that body gets acquainted to the conditions to be faced in another country.

Some Useful Resources.
National Sleep Foundation
http://www.sleepfoundation.org

American Academy of Sleep Medicine
http://www.aasmnet.org

American Insomnia Association
http://

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

Companies that provide selfless information through particip

ww.americaninsomniaassociation.org

Sleep Research Society
http://www.sleepresearchsociety.org

NIH National Center for Sleep Disorders Research
http://www.nhlbi.nih.gov/sleep

Article Written by

James Smythe

Dolphin Design

Blackpool

Learn about treadmills and ways to exercise at
http://www.justtreadmill.com

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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Have you been having trouble falling asleep at night? If so, you will want to read this article. I won't guarantee it will work for you, but it has for many others. What have you got to lose? More importantly, what have you got to gain?

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