E-Articles - Health and Fitness

Stress! We all know what it is - the pressure of life and work, the strain of keeping ahead of the game, the emotional and physical effects of having too much to do with too little time

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

to do it in, and, above all, the result of believing we have no control over what happens to us. But is there any way to predict how much stress we're under, and what effect it might h

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

Examples of combination products may in

ave on us?Indeed there is!

Many years ago, Thomas Holmes and Richard Rahe at the University of Washington interviewed 5000 people in detail about their lives and then followed them thr

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

ugh the next few years to see how their health changed. What they found has gone down in the history of stress research as a classic piece of work.It turned out that you can rate the ch

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

ances of someone becoming ill in the next year on the basis of the events that happened to them up to twelve months ago. And the more stressful the event, the higher the chances of them

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

Combination pro

becoming ill. Nothing has changed since Holmes and Rahe did their research: the things that made people stressed back in the 1960s still threaten our health. It's just that nowadays we

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

face many more stressful things than people did in the 1960s.If you want to know if you're at risk of developing a stress-related illness in the year ahead, look at this list of events

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

and see if any of them have happened to you in the past twelve months:

Death of spouse; divorce; marital separation; jail term; death of close family member; personal injury or illness

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

; marriage; fired at work; marital reconciliation; retirement; change in health of family member; pregnancy; sex difficulties; gain of new family member; business adjustment; change of

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

inancial state; death of close friend; change to different line of work; change in number of arguments with spouse; mortgage over ?100,000; foreclosure of mortgage or loan; change in re

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

sponsibilities at work; son or daughter leaving home; wife begins or stops work; begin or end university; change in living conditions; revision of personal habits; trouble with boss; ch

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

Following aspects would a

ange in work hours or conditions; change in residence; change in university/schools; change in recreation; change in church activities; change in social activities; mortgage or loan les

dd to the challenges in developing combination products:

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

than ?100,000; change in sleeping habits; change in number of family get-togethers; change in eating habits; vacation; trouble with in-laws; outstanding personal achievement; minor vio

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

lations of the law.

Broadly speaking, the lower down the list, the less stressful an item is. The higher up the list, the more stressful. Although of course this is in no way a complet

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

list of stressful events, these are the most important ones - the ones most likely to make us ill.Holmes and Rahe gave points to each item on the list and then discovered that the tota

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

l number of points a person scored was closely related to the chance of them becoming ill in the next twelve months. You can see the complete list of stressful events and how many point

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

Professional from academic institutions, pharmaceutical industries, health care indust

each is worth at the website listed in the resources box. You can also work out your chance of becoming ill through a stress related problem.What's the lesson here? We all have to live

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

in a world where there are real challenges like the ones above. There's no escaping stress, and in fact some experts have said it's good for us - but only in moderation! It's when we c

.

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

n't control what happens to us that we develop stress-related problems.So, if you think you might be at risk of stress, the answer is to act now. Find something that acts as a counterpo

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

Companies that provide selfless information through particip

int to your stress levels - relaxation, holistic therapy, a hobby, quality time with your loved ones. It might just be the difference between a serious illness and a happy, healthy life

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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