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There is little debate over the serious humanitarian crisis of the Nairobi slums, as th

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

e living conditions are atrocious. There is raw sewage everywhere, garbage pilled up an

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

Examples of combination products may in

d no toilets, sewer system of plumbing in the make shift improvised shelters. Of course

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

these are always issues when humans live in high-densities without modern civilization

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

services.

The Kenyan Government and city officials in Nairobi do not want the slums t

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

Combination pro

here and say that they are illegal and that they are not their responsibility. They wan

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

t them to go away. Of course we all know that will not happen. Today the US funds $1.6

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

illion to Kenya, take it away, use it to solve this problem now. Not next year or in a

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

decade when the slums will be double in size or more, even considering the HIV/AIDS dea

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

ths, which will spread due to prostitution, drug use, etc, into the regular population.

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

Some have said they need to set up brick factories and/or patronize local brick busin

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

Following aspects would a

esses in Nairobi. Convenient maybe, especially for the local Brick Company, but will Br

dd to the challenges in developing combination products:

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

icks and Mortar really work or is Instant Tilt up concrete construction more suited usi

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

ng river silt. What ever the case any plan needs to be done quickly and section by sect

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

on; rapid expansion, as in 1-2 months per section or less. We build things that fast li

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

ke we do in the US and here with hardly any labor, imagine if we had labor like they ha

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

Professional from academic institutions, pharmaceutical industries, health care indust

ve there?

It is time to get busy, ditch the political barriers, stop the corruption an

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

d quit the committee meetings. I certainly hope this article is of interest and that is

.

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

has propelled thought. The goal is simple; to help you in your quest to be the best in

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

Companies that provide selfless information through particip

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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