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Seasonal Affective Disorder (SAD) also known as Seasonal Depression and Winter Depression is an extreme form of common s

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

easonal mood cycles of depression that is triggered by low natural light levels, this typically occurs in the winter mon

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

Examples of combination products may in

hs from November to March. It is thought to affect 5% of the population and a further 10% of the population can suffer f

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

om the lesser form of Seasonal Affective Disorder (SAD), known as sub-syndromal SAD. People whose profession needs then

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

o work at night are extremely susceptible to suffering from Seasonal Affective Disorder (SAD). Research is still looking

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

Combination pro

in to the exact reasons why Seasonal Affective Disorder (SAD) occurs, the general belief is that the levels of the brain

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

chemicals melatonin and serotonin react to low levels of light which causes the depressions.

Typical symptoms of Seaso

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 Affective Disorder (SAD) are depression, feeling hopeless, lethargy, sadness, tearfulness, thoughts of suicide, sleep

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

ness or excessive sleep, overeating, craving for carbohydrate and weight gain. These symptoms typically disappear in the

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

spring and summer months. When these symptoms occur for three winters then Seasonal Affective Disorder (SAD) is diagnose

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

. With milder form of Seasonal Affective Disorder (SAD), sub-syndromal SAD, the symptoms typically last between January

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

Following aspects would a

and March.

Exercise, spending time outdoors in natural light and a course of light therapy which includes being exposed

dd to the challenges in developing combination products:

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

to a bright light of over 2500 lux for two hours a day will help with Seasonal Affective Disorder (SAD).

Eating the rig

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

t diet will also help with Seasonal Affective Disorder (SAD), do not eat fatty foods for breakfast or lunch, avoid fatty

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

salty, sugary snacks such as cakes, biscuits, pork pies, crisps, pizza, confectionaries, doughnuts, salami and pastries

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

avoid alcohol, salt and caffeine, eat plenty of fruit, legumes such as lentils, chick peas and kidney beans, whole gra

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

Professional from academic institutions, pharmaceutical industries, health care indust

in bread and cereals such as brown rice, oats and pearl barley, nuts and seeds, roots vegetables such as potatoes, carro

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

s and parsnips and also cruciferous vegetables such as broccoli and cauliflower, drink plenty of mineral water and herba

.

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

tea. It is best to eat, little and often throughout the day.

The following supplements may help if you are suffering f

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

Companies that provide selfless information through particip

om Seasonal Affective Disorder (SAD).

5-HTP

Co-enzyme Q10

Multivitamins and minerals

St. John’s wort

Vitamin

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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