Advice Pool - Health and Fitness

Depression is a very common word in our vocabulary. I think just about everyone over the age of about 12 years old knows a little bit about what depression is.

To define a d

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

epressive disorder officially: A depressive disorder is an illness that involves the body, mood and thoughts by affecting the way a person eats, sleeps, feels about himself a

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

Examples of combination products may in

d thinks about things.

A true depressive disorder is not the same as feeling “blue.” For a person to be diagnosed with a depressive disorder it does not mean they have a per

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

onal weakness or a condition that can be wished away. A person with a true depressive disorder cannot pull themselves together and just get better. A true depressive disorde

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

r requires appropriate treatment to improve and to recover.

There are different types of depression just as there are different types of cancers and different types of heart

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

Combination pro

isease.

Three common types of depression are:

• Major depression;
• Dysthymia;
• Bipolar disorder.

Symptoms of major depression are:

• A persistent sad, anxious,

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

or “empty” mood;
• Feelings of hopelessness;
• Feelings of guilt;
• Feelings of worthlessness and helplessness;
• Loss of interest in hobbies and activitie

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

s that were once enjoyed;
• Difficulty concentrating, remembering, making decisions;
• Insomnia, early-morning awakening, or oversleeping;
• Appetite and/or wei

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

ht loss or overeating and weight gain;
• Thoughts of death or suicide;
• Suicide attempts;
• Persistent physical symptoms that do not respond to treatment like

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

eadaches, digestive upsets and chronic pain.

It is important to note that not everyone who is depressed experiences every symptom listed. Some people experience a few sympto

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

s, other people experience many of the symptoms listed. Severity of the symptoms also varies with individuals and over time.

A major depression is diagnosed by a combination

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

Following aspects would a

of the listed symptoms when they interfere with the ability to work, study, sleep, eat and enjoy once pleasurable activities. Such disabling depressive episodes may occur on

dd to the challenges in developing combination products:

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

y once. More commonly, however, they will occur several times in a lifetime.

Dysthymia is a less severe type of depression that involves long-term, chronic symptoms that do

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

ot disable the person, but does keep him from functioning well or from feeling good.

The third type of depression discussed in this article is bipolar disorder also called ma

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

nic-depressive illness. Manic-depressive illness is not as prevalent as the other forms of depressive disorders. This disorder is characterized by cycling mood changes: se

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

ere highs (mania) and lows (depression).

Symptoms of mania are:

• Abnormal or excessive elation;
• Unusual irritability;
• Decreased need for sleep;
• Grandio

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

Professional from academic institutions, pharmaceutical industries, health care indust

e notions;
• Increased talking;
• Racing thoughts;
• Increased sexual desire;
• Markedly increased energy;
• Poor judgment;
• Inappropriate socia

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

l behavior.

To find help you can check the yellow pages under the following categories:

• Mental health;
• Health;
• Social services;
• Suicide prevention;

.

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

• Crisis intervention services;
• Hotlines;
• Hospitals;
• Physicians.

In a time of acute emergency or crisis you can seek help in the nearest hospital emerg

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

Companies that provide selfless information through particip

ncy room, which will be able to provide temporary help and will be able to refer you to other appropriate professionals.

This article is FREE to publish with the resource box

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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