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New York has just been ranked as the safest of America’s ten biggest cities in 2005, where,

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

according to the FBI, about one crime was reported for every 37 people. This is the second y

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

Examples of combination products may in

ear in a row that New York has been named America’s safest big city. How scary is that?

Whi

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

e Mayor Michael Bloomberg was quick to say the report ''shows that our innovative efforts to

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

reduce crime and increase New Yorkers' quality of life are working,'' the bigger question i

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

Combination pro

, just what is going on in our other nine biggest cities? Easygoing murder? Robbery as a wor

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

kaday job? Really bad in and out of marriage spats?

And guess what city among the leading o

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

fenders has the highest crime rate? You guessed it: the apparently unruly metropolis of Dall

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

as, where the FBI checks in with about one crime for every 12 people. One in 12 people is in

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

olved in a crime within the space of a year? Does that make you scared to go to the mall or

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

what?

Just in case you thought you were living in a city that’s safer than New York, here’s

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

Following aspects would a

the spooky rundown: San Jose came in second safest. LA came in at number three. San Diego w

dd to the challenges in developing combination products:

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

s fourth. Chicago, Philadelphia, Houston, San Antonio and Phoenix followed in that order.

N

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

ow, here’s the kicker. On a national basis, violent crime went up by 2.3% last year, but in

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

otham violent crimes – including murder, rape, robbery and aggravated assault – fell by 1.9%

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

.

So, in case you’re paranoid about living in a big city, head for New York, where you can

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

Professional from academic institutions, pharmaceutical industries, health care indust

eel safer than ever.

Just don’t do two things: Do not, whatever you do, go for a run in Cen

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

tral Park after dark. You can’t run fast enough. And at night stay on the avenues as much as

.

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

possible and, whatever you do, don’t enter dark tunnels or side streets that give you the cr

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

Companies that provide selfless information through particip

eeps just looking at them.

You don’t want to ruin New York’s safest-city reputation, do you

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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