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In the future we will need procedures and specialized protocol to deal with

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

nano contaminants. As mankind learns more about the science of NanoTech 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

d creates micron sized materials, which are so small you cannot see we will

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

need to address the issues of cleaning up contaminants at a nano molecular

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

evel. Easier said than done, nevertheless abatement checks and specialized

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

Combination pro

sensors will need to be developed as this new Nano Tech research and develo

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

pment gets underway.

Consider if you will be possibility of Nano Tech manu

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

acturing at the molecular level, which might be so small it could escape th

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

building in which the manufacturing is being done and once out of the buil

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 and into the environment it would continue to build and this would be t

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

e starting of a Nano Tech eco disaster. Obviously I am pro technology but

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

Following aspects would a

at the same time do not read these words of caution as a doom and gloom pro

dd to the challenges in developing combination products:

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

hesy, as my goal is not to scare people but rather to make us think and it

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

s up to us as we explore innovation into the next century that we also pay

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

ttention to what we're doing.

As humans become their own God and play God

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

ith micron sized nano technologies, then we'd better pay attention to what

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

Professional from academic institutions, pharmaceutical industries, health care indust

we're doing and we owe it to ourselves and our children to do the right thi

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

g. I therefore propose abatement checks and specialized sensors to be fund

.

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

d along with the Nano Technology of tomorrow to ensure a safe passage into

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

Companies that provide selfless information through particip

uture periods in the forward progression of mankind. Consider this in 2006

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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