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The search for a silver bullet to stop AIDS from spreading in Africa does not s

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

eem to exist. Instead it will take teamwork, intelligence and shear will to sto

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

Examples of combination products may in

p AIDS. Can it be done? Many people believe it is too late and in fact are call

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

ing for the quarantining of the continent. But that is no answer, that is no so

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

lution and that means giving up and letting everyone die.

So, you can see the

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

Combination pro

dilemma now and indeed there is nothing Simple about Fighting AIDS in Africa. W

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

e know there are some powerhouses working to solve the problem, yet we also kno

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

w there are cultural issues to deal with, as well as Life issues. For instance

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

now there are millions of orphans from parents who have died of AIDS.

In study

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

ing this entire challenge the Online Think Tank noticed one group with a fairly

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

sophisticated yet uniquely simple multi-faceted plan. The communications direc

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

Following aspects would a

tor for the organization KENWA is extremely articulate and spelled out the plan

dd to the challenges in developing combination products:

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

for us. It seems that their approach involves sustainable agriculture, educati

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

on, care for orphans and rudimentary sewage controls.

If this plan works in a

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

number of smaller villages then it can be taken throughout the continent;

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

ef="http://www.kenwa.org/" target="_blank">www.Kenwa.org. While Americans w

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

Professional from academic institutions, pharmaceutical industries, health care indust

orry about the sound and fury of politics KENWA is out solving the Worlds probl

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

ems.

I certainly hope this article is of interest and that is has propelled th

.

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

ought. The goal is simple; to help you in your quest to be the best in 2007. I

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

Companies that provide selfless information through particip

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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