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Depression is a broad term commonly used to describe a set of symptoms that can range from mild, requiring little or no treatment, to symptoms severe enough to interfere with a person's life on a daily basis and sometimes to the extent that life in itself can

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

become intolerable. According to the Office for National Statistics Psychiatric Morbidity Report 2001, a quarter of all adults living in the UK will experience some kind of mental health problem during the course of any one year.

Depression is a mental hea

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

Examples of combination products may in

lth problem that can affect any one of us at any time of our lives. It is indiscriminate of age, gender, culture and background. The Patient UK website states that 2 out of 3 adults will experience an episode of depression at some point and the Mental Health

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

Foundation quote that that 10% of children up to the age of 15 have a mental health disorder.

So how do we know if we are suffering from depression? Milder symptoms of depression include short bouts of low moods, lethargy, sadness and feeling a bit fed up a

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

nd out of sorts, and these will often disappear after a few days or so. However, clinical depression is more serious in that it isn't possible to just "snap out of it" and symptoms can persist for weeks, months and even years without proper help.

Some sympt

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

Combination pro

oms of depression

• Feeling tired and lethargic for most of the time
• Persistent low moods and sadness, a feeling of despondency
• Sleep disturbances, either inability to sleep or sleeping too much
• A pessimistic outlook on life
• F

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

eeling anxious and nervous
• Feelings of worthlessness or guilt
• Frightening and irrational thoughts
• Loss of pleasure in activities and lack of interest in sex
• Avoidance of social contact and social situations
• Loss of appe

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

tite or an increased appetite and associated weight loss or weight gain
• Emotional outbursts for no apparent reason
• Irritability

Each and every one of us can experience one or more of these symptoms at times without being depressed, however, i

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

f symptoms persist for more than a couple of weeks or they interrupt your ability to function on a daily basis then the chances are you might be suffering from depression.

Who suffers from depression?

Life changing events can sometimes precipitate a period

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

of depression including having a baby, death of a loved one, the breakdown of a relationship, money worries and debt, problems at work, physical illness and disability. Some groups of people are more at risk of a depressive illness than others and these incl

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

ude the long term sick and unemployed, the homeless, single parents, those who are in care or institutions, those with a past history of depressive illnesses themselves or in their family, and those battling with alcohol or substance abuse problems. Chemical

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

Following aspects would a

imbalances, genetics and physiological factors can play a role in some types of depressive disorders. Seasonal changes involving the long dark winter days and nights can bring on an episode of depression, and for others; there is no apparent or identifiable

dd to the challenges in developing combination products:

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

reason at all. According to research statistics, women are more likely than men to seek help for a mental health problem or depression however, men are more likely to commit suicide as a result of being depressed.

Common types of depression

Clinical Depre

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

ssion can be described as a depression that is severe enough to require the help and intervention of a health care professional. It is sometimes referred to as unipolar depression.

Bi-polar or manic depression manifests itself in extreme mood swings alterna

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

ting between episodes of intense euphoria and despair with relatively stable periods in between. The duration of the episodes and the gaps between them vary from person to person. During a high or manic period, the bipolar sufferer can feel euphoric, is excit

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

able, needs little sleep and can be highly creative. The lows on the other hand can be devastatingly difficult with a loss of interest in everything, feelings of despair, guilt and worthlessness and even suicidal tendencies. According to the Royal College o

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

Professional from academic institutions, pharmaceutical industries, health care indust

f Psychiatrists leaflet on depression, 1 in 10 people suffer from Bipolar.

Post Natal Depression can occur after giving birth. The symptoms are similar to those of common depression and can range from a very mild and normal period of "baby blues" lasting a

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

few days to a severe type of depression that requires clinical intervention.

Seasonal Affective Disorder or SAD is a type of depression occurring during the winter months, and is thought to be linked to a lack of sunlight so in addition to the usual treatmen

.

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

t for depression, light-therapy can be helpful.

It is not known why some people suffer from depression and not others and although some people appear more prone to episodes of depression, there is no one cause of depression and many variations in the way a d

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

Companies that provide selfless information through particip

epressive disorder can presents itself. The severity of the symptoms and the impact that depression can have on an individual's life varies from person to person but with a proper diagnosis, the appropriate help can be made available. Depression is treatable

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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