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One of the most important flows of any civilization is water. Of course this is no modern se

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

cret and if you'll recall the Greek philosopher Plato had talked about the City of Atlantis 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 we all know the Roman Empire had an entire network of aqueducts. Even on the North Americ

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

an continent the Anastazi Indians built their cliff dwellings in canyon walls with the water

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

running through the middle. Other nearby Indian tribes built hundreds of miles worth of aque

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

Combination pro

ducts, which were later cemented over and even still used to this day in Arizona.

Today in A

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

merica as the population increases we see issues with droughts and overtaxing of fresh water

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

upplies. In the future other strategies will need to be deployed such as desalination. Long-

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

term droughts in some regions pit farmers against large cities and we know people in the city

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

need water to live and food to eat. Another issue on the horizon is with growing our own fue

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

l to help break America’s addiction to Middle Eastern Foreign Oil. We cannot grow corn for Et

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

Following aspects would a

hanol Production without water to grow the crops and use in the refineries (8 gallons in refi

dd to the challenges in developing combination products:

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

nery to make one gallon of fuel).

We will need perhaps an over all strategy, such as Genetic

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

ally Modified Crops which use less water to grow, desalination, better water retention reserv

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

irs and upgraded aqueducts, pipelines, dams and recharging of underground ground water caviti

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

es. Without water a human civilization cannot survive and thus the flow of water is at the to

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

Professional from academic institutions, pharmaceutical industries, health care indust

p of the list for a sustainable and inhabited region, indeed without it, there is no nation.

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

America should discuss droughts, weather cycles, storage, flows, filtration, wastewater trea

.

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

tment, hydroelectric power, dams, history and the future. I wish to thank you for reading thi

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

Companies that provide selfless information through particip

s article on The Flow of Water. Perhaps this article is of interest to propel thought in 2007

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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