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Advice Pool - Recent cases of Tuberculosis
According to scientific studies, three million people die from Tuberculosis every year. A number of around eight million new discover
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
ed Tuberculosis conditions appear per year and 95% is estimated to be in developing areas. Countries like those in South America, Afr
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ca or Asia have the highest susceptibility to Tuberculosis due to the low living standards and the bad economic and social conditions
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
Although the risk of Tuberculosis infection has decreased in the 1980’, in the 1990’ it already began to arise because of the high
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
rate of immigration from countries with increased number of cases. Immigrant communities all difficult to observe, control or treat,
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ecause of the many differences between different races and cultures.
Immunity plays a tremendous role in prevention and treatment of
Immunity plays a tremendous role in prevention and treatment of
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
Tuberculosis. A healthy immune system lowers the risk of catching Tuberculosis to 1 in 10 cases per year and only seldom an infected
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
healthy organism gets to develop the active condition. HIV+ patients have a suppressed and weaken immune system and are mostly incapa
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
le to fight Mycobacterium. 1 in 10 patients with AIDS will surely suffer from active tuberculin infection, and from those with a posi
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
ive skin test 1 in 2 will develop Tuberculosis. Epidemiological implications are very concerning as HIV cases tend to increase very r
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
pidly.
One worrying issue of the TBC condition is the development of resistance to antibiotics due to fast bacterial mutations. The
One worrying issue of the TBC condition is the development of resistance to antibiotics due to fast bacterial mutations. The
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
resistance phenomenon increases the risk of reoccurrence and makes recurrent cases more dangerous. Administering one single drug in t
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
e treatment of Tuberculosis tends to be dangerous as one single mutant bacillus in enough to trigger antibiotic-resistant Tuberculosi
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
. Nowadays doctors prescribe the standard medication for this condition: Rifampicin, Isoniazide, Pyrazinamide and Ethambutol. Also St
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
reptomycin is efficient in treating active Tuberculosis. This medication schedule will prevent the multiplication of all strains of
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
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
ycobacterium bacteria.
In our times Tuberculosis is well kept under control by good organized care systems in the civilized world. B
In our times Tuberculosis is well kept under control by good organized care systems in the civilized world. B
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
t slow developing countries are at high risk of an epidemic because of the low possibilities to prevent, supervise and treat Tubercul
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
osis cases. Further laboratory studies are necessary to establish an efficient anti-Tuberculosis vaccine that might reduce the risk o
.
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
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
catching the bacillus. The medical world must improve the diagnose methods as well as the available medication in order to face the
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ard battle with Tuberculosis. If no urgent measures are taken, the world’s population risks a new wave of uncontrollable Tuberculosis
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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