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How many times when you've found yourself under stress has one of your first reactions been to have a drink? For many people the answer if quite often and, although it's n

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

ot heard quite so often these days, the phrase 'she drove me to drink' springs to mind.

Having the odd drink in times of stress to 'calm your nerves' probably won't do yo

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

Examples of combination products may in

any harm, but what happens when we turn this one on its head? Can drinking too much alcohol actually cause stress?

There's little doubt that a moderate alcohol intake ca

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

be beneficial effects and research suggests that small amounts might even improve mental function and increase performance in the area of problem solving. But, there are

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

lso numerous studies that show that large quantities of alcohol, especially when you drink alcohol over a long period of time, can actually create stress.

Alcohol, when c

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

Combination pro

nsumed in large amounts, stimulates the hypothalamus, adrenal and pituitary glands and one result of this is an increased level of both cortisol and adrenaline within the

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

ody. Neither of these will cause stress directly, but both play a significant role in reinforcing the symptoms of stress.

For example, when you're under heavy stress it 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

more difficult to concentrate. Similarly, high alcohol intake will also produce the same exact effect. The obvious consequence of this is that the heavy drinker gets a do

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

ble whammy whenever he's presented with a situation that calls for mental clarity.

Studies also suggest that chronic drinkers suffer symptoms which are similar to those s

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

en in children with Attention Deficit Hyperactivity Disorder (ADHD). More interestingly, however, the same studies show that the children of these same drinkers have a hig

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

er incidence of actual ADHD.

It may also be true therefore that, while the stress of parenting may lead to drinking, adult drinking may in fact promote the circumstances

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

Following aspects would a

that incite the parent to drink. This may well be a factor in producing symptom in children which later lead to adult stress.

One of the best ways to relieve stress is th

dd to the challenges in developing combination products:

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

ough exercise and people who lead an active life including sport or other physical activity are generally seen to have lower incidences of stress. Unfortunately, one of th

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

side effects of excessive alcohol consumption is a decrease in the level of exercise so that heavy drinkers often lose this valuable release valve.

Similarly, high alcoh

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

l intake suppresses the appetite and replaces much needed calories normally obtained from a balanced and healthy diet with calories derived from drink. This, in turn, lead

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

to a general decline in health lowering the drinker's defenses against stress.

No matter what the circumstances, excessive drinking inevitably results in a vicious cycle

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

Professional from academic institutions, pharmaceutical industries, health care indust

with stress initially causing the individual to turn to drink and drink then making it more difficult to deal with the factors which lead to stress in the first place.

Th

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

only way out of this cycle of course is to find another way to deal with stress in the first place and to get rid of the crutch which many people feel drink provides. Thi

.

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

means first and foremost adopting a realistic attitude to the challenges of life and meeting and overcoming its hurdles, rather than being stressed by them. A good progra

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

Companies that provide selfless information through particip

of exercise and diet can also help, but a long-term solution will only result from an admission that the underlying problem in tackling stress effectively actually exists

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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