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Clinical depression (also called major depressive disorder, or unipolar depression when compared to bipolar disorder) is a state of intense sadness, melancholia or despair that has advanced to the point

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

of being disruptive to an individual's social functioning and/or activities of daily living. Depression affects people differently. Some feel down for extended periods of time; for others the feelings of

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

Examples of combination products may in

depression come and go. Depression is a mood disorder that causes you to feel sad or hopeless for an extended period of time. More than just a bout of "the blues" or temporary feelings of grief or low en

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

rgy. Many people identify the feeling of being clinically depressed as "feeling sad for no reason", or "having no motivation to do anything." One suffering from depression may feel tired, sad, irritable,

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

lazy, unmotivated, and apathetic.

Clinical depression is not just grief or sadness. Clinical depression is generally acknowledged to be more serious than normal depressed feelings. It often leads to co

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

Combination pro

stant negative thinking and sometimes substance abuse. Extreme depression can culminate in its sufferers attempting or committing suicide. There are three main types of depression; unipolar disorder (maj

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

r depression), bipolar disorder (manic depression) and dysthymia (prolonged sadness). Major depression usually strikes people between the ages of 25 and 44, although it can affect any person at any age.

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

For most people, episodes of major depression last from six to nine months. Feelings of total indestructibility are common, and the manic person may believe for example that not even moving cars can sto

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

him or her, or that he or she can fly. They experience delusions and hallucinations and sometimes talk so fast that their speech becomes illegible.

Causes of Clinical Depression

1. Genetic Predisposit

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

on (Hormonal imbalance ).

2. Medical conditions (Neurochemical ).

3. Dietary .

4. Alcohol and other drugs.

5. Sleep quality.

6. Certain styles of thinking.

Symptoms of Clinical Depression

1. Persi

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

tent feelings of sadness, irritability, or anxiety

2. Overreaction to irritations

3. Loss of interest in activities previously enjoyed, including sex

4. Sleeping too much, sleeping too little

5. Losi

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

Following aspects would a

g or gaining weight.

Treatment of Clinical Depression

Medication that relieves the symptoms of depression has been available for several decades such as citalopram (Celexa), fluoxetine (Prozac), paroxe

dd to the challenges in developing combination products:

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

ine (Paxil), and sertraline (Zoloft). Under some circumstances, medication and psychotherapy may be more effective than either treatment separately. Family of drugs includes fluoxetine (Prozac), paroxeti

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

e (Paxil), escitalopram (Lexapro), citalopram (Celexa), and sertraline (Zoloft). These antidepressants typically have fewer adverse side effects than the tricyclics or the MAOIs, although such effects as

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

drowsiness, dry mouth, nervousness, anxiety, insomnia, decreased appetite, and decreased ability to function sexually may occur. Serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine

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

Effexor) and duloxetine (Cymbalta) are a newer form of antidepressant that works on both norepinephrine and 5-HT.Selective serotonin reuptake inhibitors (SSRIs) are medications that increase the amount o

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

Professional from academic institutions, pharmaceutical industries, health care indust

the neurochemical serotonin in the brain.

Norepinephrine (noradrenaline) reuptake inhibitors (NRIs) such as reboxetine (Edronax) act via norepinephrine (also known as noradrenaline). Tricyclic antidepr

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

ssants are the oldest and include such medications as amitriptyline and desipramine. Tricyclics block the reuptake of certain neurotransmitters such as norepinephrine (noradrenaline) and serotonin. They

.

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

re used less commonly now due to the development of more selective and safer drugs. Monoamine oxidase inhibitors (MAOIs) such as phenelzine (Nardil) may be used if other antidepressant medications are in

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

Companies that provide selfless information through particip

ffective. Because there are potentially fatal interactions between this class of medication and certain foods, particularly those containing Tyramine. electroconvulsive therapy, are used in severe cases

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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