Delicious - Reference and Education

When considering abatement strategies to remove bio-toxins, bio co

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

ntaminants, insects, noxious weeds or pollution it is necessary to

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

Examples of combination products may in

have a very comprehensive and non-linear set of protocols and proc

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

edures to prevent the further harming of the local ecosystem and e

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

vironment.

If we fail to look at the bigger picture we get into t

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

Combination pro

ouble and invariably end up verbally character assassinating some

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

chemical corporation who made the abatement product or chemical wh

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

n in actuality the chemical solves the problem but when it is mixe

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

wrong or used wrong or concentrated too much and sprayed too clos

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

e to streams, water supplies or in high winds the issues arise.

A

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

ditionally we need to stop blaming chemical companies and start co

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

Following aspects would a

sidering which chemicals to use in what amounts to solve the probl

dd to the challenges in developing combination products:

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

em over time rather than nuking the area so to speak with insane p

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

otocols and mixed matched procedures which some might even conside

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

foolish.

You see the abatement procedures need decision matrixes

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

, which consider all aspects of the problem and the solution as we

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

Professional from academic institutions, pharmaceutical industries, health care indust

l as ERSI 4D software with supercomputing capabilities to insure t

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

ings are done correctly. We must have a more comprehensive and Non

.

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

-Linear Strategy in abatement of those things, which may harm the

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

Companies that provide selfless information through particip

merican People, their environment or bodies. 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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