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After considerable thinking on the Nairobi Slums by the Online Think Tank it seems like an overwhelming situation. The Slums need a ma

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

ster plan and that would have to include bulldozing and starting over. For many that sounds too harsh and there are sure to be riots 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

nd protests once the bulldozing begins. But rebuilding the slums with rudimentary structures would solve the current problems there.

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

Unfortunately in reviewing all this I have determined that upgrading the slums in Nairobi will lead more home-less starving people to

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

come to the city, thus continuing to expand the slums and worsen the problem. I also believe that HIV/AIDS will have a greater chance

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

Combination pro

of entering the rest of the population much faster than it already is in that case and many of those people in the city of Nairobi get

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

onto airplanes and fly to places like the USA.

Additionally, if you fix one slum, you have to fix them all, but there is not the pol

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

itical will. Further there are 3-5 million in the slums in Mexico City? So, no need to go half-way around the world for a photo-op for

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

these politicians who love to make this a political issue. Do such plans for a project embolden me to get involved? NO. Because, any

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

help in the slums will increase birth rates there and lead to more people being born into poverty.

As bad as it sounds actually I am

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

or putting sterilization into the food. I am for turning people away from the slums, bulldozing, some upgrading with stipulations incl

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

Following aspects would a

uding; no drug users, no criminals, rapists, etc. I think what many well-intentioned non-profit groups are doing there is a waste as i

dd to the challenges in developing combination products:

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

t does not solve the real problems.

Some groups wish to put animals into the slums to provide milk and protein, yet that is ridiculou

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

s, it takes energy to feed animals and they make more waste and further assist in causing disease in such tight quarters and what abou

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

t the breeding of animals to make Anthrax and international terrorist recruiting?

When mentioning all these facts someone explained t

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

hat such realistic solutions would deter from one's credibility. But of course credibility is not something one should desire from lin

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

Professional from academic institutions, pharmaceutical industries, health care indust

ear thinkers who run around thinking they are helping and causing other problems in the future, many worse challenges. It is time for

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

the Kenyan Government and the US to get serious about this issue, even if it means cutting off the $1.6 Billion in aid there.

It is t

.

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

ime to get tough, no more committees. I certainly hope this article is of interest and that is has propelled thought. The goal is simp

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

Companies that provide selfless information through particip

le; to help you in your quest to be the best in 2007. I thank you for reading my many articles on diverse subjects, which interest you

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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All children grow up and when they start driving car insurance has to be purchased for them. There are several reasons why insurance for young drivers is so high...

The ratings for timber windows internationally are better than those for metal or PVC windows and are recommended by the WWF as timber windows require less energy, are more efficient and less CO2 is emitted into the atmosphere in their production.

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