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Welcome and thank you for showing your interest in this free series which will explore the different treatment options available for bipolar disorder. In this series you

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

can expect to discover:

Part 1 - What is bipolar disorder and how is it treated.
Part 2 - What medications are effective in treating bipolar disorder.
Part 3 - Eff

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

Examples of combination products may in

cts of nutrition on bipolar disorder, psychotherapy and other treatments.
Part 4 - Co-occuring illnesses and genetics research.
Part 5 - Brain imaging and what does

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

it show.
Part 6 - Treatment research
Part 7 - Where to find help

Let's get to it :)

Introduction

Bipolar Disorder is a mental illness that causes peop

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

e to experience extremes in moods from high to low, sometimes within a single day or week. As of 2005 there is no known cure for the condition previously known as manic-de

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

Combination pro

ressive illness. But scientists, researchers and physicians are optimistic as they work to improve the prospect of a reasonably normal life for sufferers and those they lo

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

e. The general public must become more aware of this illness in order to take action early, thereby avoiding damaging consequences. Patients themselves ought to pay heed t

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

whatever therapy is recommended by their physician, whom they should know well and trust. Only in this way will people be in the position to successfully manage this pot

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

ntially devastating illness.

Early Treatment is Important Contrary to the hopes of many parents, Bipolar Disorder cannot be diagnosed at birth. Symptoms usually appear in

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

dolescence or early adulthood. Unless the sufferer is treated, those symptoms will recur throughout the course of life. Some people pug up with bipolar disorder much longe

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

than they should, only because they do not realize they have the illness. If patients are not diagnosed early, and cared for, Bipolar Disorder becomes more difficult to t

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

Following aspects would a

reat. The longer a person continues without medical attention, the higher the risk of alcohol and substance abuse, suicide, and serious issues at home, work and school. Pr

dd to the challenges in developing combination products:

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

per treatment is very important so that the bipolar disorder patient can begin to stabilize his or her moods. Exaggerated mood swings are at the heart of this illness, and

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

in many ways define it.

So How is Bipolar Disorder Treated?

Bipolar Disorder is treated through a combination of medication and psychological treatment and oftentim

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

s, nutrition. As with many conditions or illnesses, a collective approach tends to be most effective.

A medical doctor (most often a psychiatrist) with expertise in the d

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

agnosis and treatment of mental disorders generally prescribes medication. Treatment should be ongoing, and not on-and-off. Even with continuoustreatment, mood swings may h

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

Professional from academic institutions, pharmaceutical industries, health care indust

ppen, but if a doctor is notified, he or she can adjust the treatment plan to suitthe patient’s need. It is critical that patients work very closely with their doctor, commu

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

icate openly and honestly regarding questions or concerns, and feel comfortable discussing treatment options.

Many bipolar disorder patients record their daily moods, the

.

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

r treatments, sleep patterns and life events on a chart. By charting their day, sufferers and their loved ones become more aware of possible triggers. As a consequence, th

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

Companies that provide selfless information through particip

y can effectively guide the treatment process.

In the next issue we'll explore the different medications used to treat bipolar disorder.

Copyright 2005 LifeWithBipolar.co

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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