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Have you ever wondered why our hearts go to our sweet hearts, we tend to miss them very intensely when it rains, we feel low, even feel like weeping alone on a cloudy day…w

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 sometimes go through sudden mood change with no exact reason behind, we tend to eat more and sleep more and experience depression, lethargy, fatigue, cravings for sweets

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

Examples of combination products may in

and starches, headaches, sleep problems and irritability as the temperature drops. The influence of season on human mood and his energy level is undeniable, and time and ag

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

ain the psychologists have studied and documented the facts.

Seasonal Affective Disorder is not only a couple of symptoms related to winter blah; it is mostly associated w

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

th day light, that is why SAD is prevalent in high latitude and mid latitude areas. People who live in the Arctic region are more susceptible due to the fact that they are

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

Combination pro

affected by polar nights, prolonged periods of overcast weather also induce SAD, however, It is more serious disorder, sometimes requiring hospitalization when the depressi

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

on is aggravated and turns into dysthymia or clinical depression. Our biological internal clocks or circadian rhythm goes through a shift as seasons change, and our biologi

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

al clocks fall out of our daily schedules. January and February are the months when a SAD sufferer suffers the most, young people and women are comparatively more victimize

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

d.

The most frequent symptoms are recurring symptoms of depression and excessive eating and sleeping, weight gain during the fall or winter months. The patient would fully

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

cutback from depression in the spring and summer months. SAD symptoms occur in them with no non-seasonal depression episodes and seasonal episodes significantly outnumber

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

on-seasonal depression episodes. The patient craves for sugary and starchy foods during the winter. Possible cause of the disorder, as the researchers and psychologists say

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

Following aspects would a

, is Melatonin, a sleep-related hormone secreted by the pineal gland in the brain. This hormone is said to cause symptoms of depression, because it is produced at increased

dd to the challenges in developing combination products:

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

levels in the dark. Therefore, when the days are shorter and darker the production of this hormone increases and people are affected.

Apart from antidepressants like Xana

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

x, photo therapy or bright light therapy is proved to suppress the brain’s secretion of melatonin. The use of bright light box at a dose of 10,000 lux for 30-60 minutes per

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

day has given good results. During these minutes the eyes should remain open but should not stare directly to the light. The light box is a bank of white fluorescent lights

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

on a metal reflector and shield with a plastic screen. The light therapy may take several weeks to treat the depression but some patients have shown results within one wee

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

Professional from academic institutions, pharmaceutical industries, health care indust

k. For patients with mild symptoms, spending time in the sun or arranging picnics or outdoors to receive more sunlight may be helpful. A daily walk of an hour in the sunlig

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

t during the winter is more effective than two and a half hours of light therapy. When photo therapy does not work, an antidepressant drug proves to be effective in reducin

.

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

g or eliminating SAD symptoms. But before taking an antidepressant, a doctor’s advice is required so that a proper antidepressant medication is taken.

There is no cure for

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

Companies that provide selfless information through particip

SAD discovered yet; nevertheless, the above mentioned treatments are helpful in managing the winter blues so that one can go though all the seasons in the year comfortably

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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