Advice Pool - Reference and Education

When constructing NanoTubes and other super tiny devices espe

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

cially those which replicate themselves one has to be careful

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

Examples of combination products may in

not to allow them out side the manufacturing facility and int

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

the wild; that is to say outside the building.

They are 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

mall that most membrane filters cannot stop them from getting

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

Combination pro

out and therefore their needs to be perhaps liquid gaps betwe

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

en filters. But even the walls of a building may not be secur

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

enough.

We know from infrared heat escaping detection devic

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

s that air escapes around window sills and we also know each

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

ime we open the door we escape the building along with the ai

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

around us and the microscopic material stuck to our clothes

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

Following aspects would a

as well.

Now consider things smaller than a speck of dust by

dd to the challenges in developing combination products:

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

100-fold or a 1000-fold getting outside the building and then

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

continuing to replicate on their own. For how long; well, how

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

about forever for starters? Interesting and intriguing indeed

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

isn’t it?

Well, what can we do about this? It appears we nee

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

Professional from academic institutions, pharmaceutical industries, health care indust

d additional filters ionic charged airflow devices to clean t

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

e outside air as well, otherwise that which escapes could bec

.

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

me a very huge problem and this is why abatement issue of Nan

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

Companies that provide selfless information through particip

Tech Construction is so very important. 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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Advice Pool - Abatement Issues in NanoTech Construction

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