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The first sentence was; Not in my backyard! And that is how the presen

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

tation to the City Council began. We came with information and data 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 a perfect plan, but the Sierra Club Lady and resident hippie stood

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

up just before we started talking and said; not in my backyard! Well,

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

you can imagine how I thought that night might end.

Luckily for us we

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

Combination pro

were told in advance the objections of this particular resident hippi

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 and her friends she brought with her to the City Council Halls. Her

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

objections were quite simple in that a truck wash would bring more tru

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

cks off the freeway and trucks put out a CO2 and therefore there would

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

be more pollution in the town if we put in a truck wash. But the tow

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

n did not start for good four miles away and since we were on the far

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

Following aspects would a

side of town by the interstate the wind would blow the pollution away

dd to the challenges in developing combination products:

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

from the City and not into it.

It is always amazing the logic that pe

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

ople come up with when they try to fight the business owner who is try

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

ing to make a return on his investment. After all it is not her prope

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

rty and yet she was so concerned about a truck wash being there why no

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

Professional from academic institutions, pharmaceutical industries, health care indust

t buy the property and plant flowers and start a hippie movement and a

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

pot smoking shrine?

Well guess what the presentation went off flawle

.

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

ssly and we answered the ladies objections and today her son is a mana

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

Companies that provide selfless information through particip

ger of one of our truck washes; go figure? Consider all 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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Digg It - Presentations to City Councils for Truck Wash Locations

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