Advice Pool - Health and Fitness

Despite advances in treatments available, tuberculosis (TB) still remains a global pandemic. One third the human population is currently infected with tuberculosis. What is tuberculosis?

The disease tuberculosis is caused by the bacteria Mycobacterium tuberculosis. Tuberculosis can affect any

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

part of the body but usually infects the lungs. Tuberculosis is spread through airborne droplets occurring when an infected individual sneezes, talks, or coughs. However, prolonged exposure to the infected individual must occur before you may become infected. The body may harbor the bacteria

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

Examples of combination products may in

hile the immune system prevents sickness. For this reason, there are two forms of TB: latent tuberculosis and active tuberculosis.

With latent tuberculosis, the immune system is able to prevent the bacteria from growing. The tuberculosis bacteria remain alive within the body but are inactive a

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

t this time. However, the bacteria can become active later in life. Those with latent tuberculosis have no symptoms, do not feel sick, are not contagious, and may develop TB later in life if they do not receive treatment.

Active tuberculosis simply means that the tuberculosis bacteria are grow

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

ng within the body causing an active infection. Signs and symptoms of active tuberculosis include fatigue, slight fever, chills, night sweats, loss of appetite, unintended weight loss, a cough that lasts three or more weeks producing discolored or bloody sputum, and pain with coughing or breathi

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

Combination pro

ng. Active tuberculosis is highly contagious.

What is causing the tuberculosis pandemic? Improved public health programs have helped to create a steady decline of tuberculosis cases in the United States. However, the problem is far from solved. Factors that contribute to the spread of tuberc

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

losis in the U.S. and elsewhere include the increase in number of foreign born nationals, crowded living conditions, increase in drug resistant strains of tuberculosis, lack of access to medical care, and the increase in poverty.

Poorly ventilated and crowded conditions help to spread TB. This

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

is one reason tuberculosis cases have reached epidemic proportions. Although the incidence of TB cases in the U.S. is declining, the incidence in other parts of the world is increasing. Half of the reported cases in the U.S. (in 2000) occurred in individuals that were born outside of the U.S.

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

ndividuals that live in poverty, move or migrate often usually do not finish the tuberculosis treatment. This is leading to drug resistant forms of tuberculosis.

Drug resistant strains of tuberculosis are a serious problem. Tuberculosis bacteria have developed strains of the bacteria that are

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

resistant to each of the major tuberculosis medications. There are also strains of tuberculosis that are resistant to at least two tuberculosis medications. This multidrug-resistant TB (MDR-TB) is posing an even deadlier threat to those affected. Individuals affected with MDR-TB are much more

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

ifficult to treat requiring a long term therapy of up to two years. The medications required to treat these strains can cause serious side effects. This is one great reason to complete the entire course of medication as prescribed by your doctor.

Certain factors increase your risk of contracti

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

Following aspects would a

g tuberculosis. An individual in an immunocompromised state is at risk of developing TB. A number of factors can cause the immune system to be in a weakened state. Some diseases can suppress the immunity such as diabetes, HIV/AIDS, and silicosis. Certain medications can affect the body’s immu

dd to the challenges in developing combination products:

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

ne system which includes chemotherapy drugs and corticosteroids. An increased risk of reactivated tuberculosis has been associated with the use of arthritis medications Enbrel and Remicade.

Individuals within close proximity of those infected with tuberculosis are at an increased risk of develo

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

ing disease. Individuals in areas of high rates of tuberculosis (Asia, Africa, Latin America, former Soviet Union) have an increased risk of developing tuberculosis. Certain races (Hispanics, American Indians, Asian Americans, African Americans) in the U.S. are at risk of developing tuberculosi

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

s. What other factors may increase your risk of developing tuberculosis?

The older adult is at an increased risk of developing tuberculosis due to a weakened immune system. Individuals who are malnourished, lack adequate medical care, or who suffer from long term drug or alcohol abuse are at i

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

creased risk of developing tuberculosis. Health care workers are at increased risk of developing tuberculosis also.

If you develop any of the signs or symptoms listed above, you should seek medical advice. Individuals with HIV should be tested for tuberculosis, since the leading cause of death

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

Professional from academic institutions, pharmaceutical industries, health care indust

in the AIDS patient is tuberculosis. HIV and tuberculosis have a deadly symbiosis, in which TB increases the rate at which the AIDS virus replicates and HIV reactivates inactive TB. Health care workers are usually tested at least yearly for tuberculosis by Mantoux test. Individuals with laten

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

tuberculosis reveal a positive Mantoux even though no symptoms of the disease are evident. Tuberculosis is also tested by chest x-ray and culture tests (urine, sputum).

Tuberculosis is a preventable disease. There are a few measures one can take to protect their health. First, you should be

.

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

tested regularly. If you have an immune suppressing disease, live or work in a prison or nursing home, were born in a TB prevalent country, or have other risk factors, then a Mantoux test should be done every six months.

If you test positive without symptoms, speak with your doctor about treatm

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

Companies that provide selfless information through particip

nts to reduce the risk of developing active tuberculosis. The most important step you can do for the public and yourself is to finish the entire course of medication. Treatment that is stopped to early allows the bacteria a chance to mutate to a drug resistant form.

Copyright 2006 Kristy Hauge

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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