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The use of light therapy as a treatment for SAD syndrome, properly named seasonable affective disorder, is well known to, and generally recommended by, the medical profession. Millions of poor souls are affected

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

by seasonal affective disorder and while most of us look forward to Christmas all they experience is depression and a craving for starchy and sugary foods.

Sufferers become lethargic, feel tired even after slee

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

Examples of combination products may in

p, and can suffer physical pain in the joints and abdomen. They can feel despair, guilt with nothing to be guilty about, and severe anxiety. Frustration and irritability for no apparent reason are also common.

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

To some it is mild and to others it can be very severe to the point of suicide. It is not, therefore, a condition to be ignored and light therapy definitely helps in most cases.

OK, perhaps they do enjoy Christ

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

mas with their families, but the depression is not helped by the weight that they can put on through the excess of sugars and starches that they consume through no fault of their own. Not for them New Year resol

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

Combination pro

tions to keep off the sugars and starches. The credit card bills at the end of January do not help either.

So how can light therapy help SAD disease, as people call it, though it is actually a syndrome and not

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

a disease? It can’t be ‘caught’ or passed from one person to another and it occurs in varying degrees. It is sometimes referred to as SAD disorder and Winter Blues, but what you call it is irrelevant. Professi

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

nal psychologists agree on the use of light therapy as a treatment for SAD, and lamps are available that provide the full effect of natural sunlight.

It is very important to understand that this is a very real c

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

ondition, with potentially very serious consequences if not treated properly. Many sufferers feel isolated due to them feeling not fully understood by most people. It is not something they can just ‘snap out 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

or be resolved by them ‘pulling themselves together’. It must be recognized by sufferers and their families that light treatment as a therapy for SAD can help their symptoms and, in the most severe cases, save

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

lives. Not only life itself, by the treatment of potential suicides, but also the quality of life of the millions of less serious cases.

Some sufferers are lucky enough to work in an environment where their exp

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

Following aspects would a

osure to sunlight can be maximized, but others do not. Office workers with desks beside a window can adjust their seating as to achieve this, but those working in windowless environment, which is the case in mos

dd to the challenges in developing combination products:

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

manufacturing units, are unable to. Many with the potential to suffer from this disorder escape it through an outdoor life, or holding a job that involves predominantly outdoor work, such as the armed forces and

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

construction industries.

With fewer daylight hours in winter, it is theoretically possible for an individual to have weeks with very little exposure to natural sunlight. Perhaps this is a slight exaggeration,

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

ut not everybody works only five day weeks. SAD is not a condition considered by employers in their provision of facilities for the disabled, probably because it is either not though of as a disabling condition,

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

or because of the general ignorance about it.

Melatonin is a hormone found in all humans, and is produced in higher levels by the body in the absence of sunlight. Melatonin is known to have something to do with

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

Professional from academic institutions, pharmaceutical industries, health care indust

the sleep-wake regulation, and people tend to get sleepier with higher levels of melatonin. It makes sense, since it is produced at sundown, and its production declines with dawn. So melatonin production may ha

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

ve a lot to do with SAD disease. It is as uncertain as is the knowledge of the effect of melatonin in the body, but it is under investigation. Do not, therefore, as some suggest, use melatonin as a treatment fo

.

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

seasonal affective disorder, since it may in fact aggravate it.

Far better, as the medical profession agree, is to use light therapy. Light therapy as a treatment for SAD is the simplest available, and is also

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

Companies that provide selfless information through particip

portable. Light therapy can be used at home and in the workplace. It is just a shame for the sufferers that it has not been given the publicity and the research that it should, due it being a seasonal disorder

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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