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Clinical depression is quite a common condition and affects around 16% of the population at least one time in their lives, and it is described it as

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

a situation that has got to the point of disruption to an individual's social life and/or their daily duties such as work and home life.

Clinical

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

Examples of combination products may in

epression is found more in some Western countries like Australia where one in four women and one in six men will be found to suffer from it. It has

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

een found that clinical depression is the main cause of disability in the US and the World Health Organization tell us that it is expected to become

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

the secondary leading cause of disability in the world by 2020 after heart disease.

Clinical depression symptoms are varied and often include feeli

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

Combination pro

gs and emotions that can be found in people without depression. Due to this health practitioners have to determine a proper diagnosis by applying a

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

umber of symptomatic criteria as suggested in the DSM-IV-TR or ICD-9/ICD-10.

The DSM-IV-TR criteria tells us for accurately diagnosing clinical dep

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

ression, a person may be diagnosed as clinically depressed if he/she exhibits one of the following two elements for a period of two weeks or more:

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

depressed mood or being unable to find pleasure from usually pleasurable events (otherwise known as Anhedonia).

Combining any of the two elements

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

bove with any five of the list of other symptoms experienced over the same two-week period is sufficient to diagnose clinical depression in a person

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

* Being overwhelmed by feelings of sadness or fear

* Or inability to feel emotion (feeling empty)

* Finding less pleasure or interest in all, or

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

Following aspects would a

almost all activities, even activities that they used to find pleasure in

* A changing of appetite and a noticeable affect either up or down in wei

dd to the challenges in developing combination products:

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

ht.

* Disruptive sleep patterns, which may cause insomnia, loss of REM sleep, or excessive sleep otherwise known as hypersomnia.

* Agitation affec

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

ing the psychomotor functions, or retardation

* Feeling drained, a mental or physical loss of energy.

* Feelings of guilt, helplessness, despair,

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

anxiety or fear

* Trouble concentration or making decisions

* Slowing of cognition, including memory

* Recurrent thoughts of death or suicide inc

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

uding trying to kill oneself

A person can be diagnosed with clinical depression despite the fact that they do all of the criteria. As well as, the

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

Professional from academic institutions, pharmaceutical industries, health care indust

ebate over the relative importance of genetic or environmental factors, or gross brain problems as against psychosocial functioning, is still curren

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

ly ongoing.

Treating clinical depression may be different for each individual and that is important to remember. In fact, there are as many methods

.

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

used to treat clinical depression as there are symptoms. Never the less, the two main methods used when treating the condition are usually medicatio

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

Companies that provide selfless information through particip

and psychotherapy. In the event that medication fails, it is possible that a third treatment known as ECT or electroconvulsive therapy may be tried

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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