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Have you or someone you know been diagnosed with Chronic Obstructive Pulmonary Disease (COPD)? Did you know that according to the American Lung Association COP

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

D is the fourth leading cause of death in the United States? If you have COPD don't feel alone; over 11 million adults 18 and over were estimated to have COPD

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

Examples of combination products may in

in 2004.

The term COPD refers to two lung diseases; chronic bronchitis and emphysema. Both of these diseases frequently co-exist and the diseases are characte

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

rized by obstruction to airflow that interferes with normal breathing. The primary risk factor for COPD is smoking, with approximately 80 to 90 percent of COPD

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

deaths caused by smoking. Other risk factors include second-hand smoke, air pollution, a history of childhood respiratory infections and heredity. COPD is a d

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

Combination pro

isease that primarily affects the elderly; it is not typically diagnosed until the fifth decade in life. Most smokers use tobacco for twenty years or more befo

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

re experiencing symptoms.

The process of respiration involves the body constantly taking in oxygen and releasing carbon dioxide. Low levels of oxygen in your

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

blood means that you are not receiving enough oxygen on your own through normal respiration. If you are a smoker, a productive cough that is usually worse in t

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

he morning is an early warning sign of COPD. Depending on the severity of your symptoms, your physician may recommend a test to determine if you require oxygen

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

therapy.

Symptoms of COPD:

* Dyspnea (shortness of breath), especially during physical activity

* Chronic cough, breathlessness, wheezing

* Fatigue

* Hem

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

ptysis (coughing up blood)

* Tightness in chest

* Persistent lung infections (pneumonia, flu, etc.)

* Chronic mucus production

* Increasing morning headach

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

Following aspects would a

es

Severe COPD Symptoms Include:

* Cyanosis (blue skin color)

* Edema (fluid retention in legs and feet)

* Bloated abdomen

Oxygen therapy for COPD patient

dd to the challenges in developing combination products:

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

s can have a multitude of benefits. Using supplemental oxygen allows you to do activities with less shortness of breath. Receiving oxygen can help you live a l

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

onger life by protecting your heart and other organs from further damage. You will sleep better and longer through the night which will improve daytime alertne

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

ss.

If your physician determines that you have COPD and require oxygen therapy, there are three ways for you to receive supplemental oxygen:

1) Compressed ox

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

ygen cylinders

2) Liquid oxygen cylinders

3) Oxygen concentrators

Many COPD sufferers discover that oxygen concentrators are the best system for receiving s

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

Professional from academic institutions, pharmaceutical industries, health care indust

upplemental oxygen. Today's inventive oxygen concentrators offer a level of mobility and convenience unheard of just a few years ago. Compressed and liquid oxy

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

gen systems require large cylinders that have to be refilled and handled and stored with care. Oxygen concentrators simply plug into an electrical outlet. Some

.

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

portable oxygen concentrators feature rechargeable batteries and can be plugged into your car's accessory outlet for easy travel.

If you have COPD symptoms y

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

Companies that provide selfless information through particip

ou should see your physician immediately. If oxygen therapy is recommended, discover how an oxygen concentrator can improve your health and sense of well-being

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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