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Simply put, room and contents begin to burn at a very rapid rate during the growth stage of the blaze. Heat is radiated from burning combustibles, then reradiated by the walls and other structural elements. This "thermal feedback" causes an e

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

ven greater acceleration of heat. Finally, the entire room and its contents ignite with violent and explosive force.

Our culture and its technology have served as a major contributor to the problem of flashover. Up until the 1960's, the aver

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

Examples of combination products may in

ge residence contained natural products made up of woods, cottons and other fabrics. Back then it often took a blaze from 8 to 10 minutes to grow from inception to the fully-involved stage. But in our present day world of synthetics, plastics

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

and hydrocarbons, the same room takes only 2 to 3 minutes to reach the peak of fire growth. This accelerated rate of burn has become a major concern for firefighting teams and the officers who command them.

Oddly enough, it was a prevention

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

tool designed to save lives that first brought Flashover to our attention - the home smoke detector. In days gone by, fires were typically unreported until they vented from a window, sending the fastest civilian running for the Gamewell Box.

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

Combination pro

Today, because of the effectiveness of early warning systems, departments are now notified of fires much, much earlier.

Companies now arrive on the scene during the growth stage, entering the structure at the worst possible time, just prior

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

o flashover. Combine this with the standing practice of aggressive interior attack, and one can quickly understand why firefighters have become more aware, and much more concerned, of the phenomenon. The simple fact is - we're seeing it much

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

more often.

See Flashover Photos: http://www.flickr.com/photos/louangeli/sets/72157594315369414/

Low Tech System with High Tech Results

In Europe, where line of duty deaths, and interior attack, are quite rare, the multi-national fire comm

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

nity was shocked, when in 1987, two Swedish firefighters lost their lives to a flashover incident. In response, training officers in Stockholm saw the need to create an awareness program for the brigade's firefighters. They developed a rudime

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

ntary simulator that allows attack teams to identify potentially dangerous environments during the early stages of the firefight. Their primary goal: to demonstrate to suppression teams how to escape a flashover and exit safely.

On the fire

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

raining grounds near Stockholm, I prepare to videotape the special fire training simulator designed by the Swedes. I was expecting a high-tech block structure, with thermal sensors, gas jets, and emergency sprinklers. Instead, I'm led to a se

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

Following aspects would a

ries of overseas shipping containers, that have been laid out in random fashion to represent various firefighting scenarios.

According to Roland Lindquist, Director of the Raddnings Verket, (The Swedish Fire Rescue Services Board) the system

dd to the challenges in developing combination products:

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

was adopted by all departments in Sweden by 1990. Instructors there further refined both classroom and hands-on curriculum, and today every Swedish firefighter is required to take this special training course. It's dubbed the Swede Survival S

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

ystem, and it's taken Europe, and this nation, by storm.

View firefighting images on Flickr

6,000 miles away from Stockholm, in America's heartland, Indianapolis firefighters carry on a tradition that's been passed down from generation to g

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

neration -- mounting an aggressive interior attack. Like so many departments nationwide, Indy fire administration have armed all front-line personnel with the very best in protective equipment. A secure envelope, that guards firefighters from

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

intense heat and vicious flames. But some say that this very same envelope denies firefighters the use of an important God-given safety regulator – the sense of feel. In short, present day protective gear is so damned good, it's difficult t

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

Professional from academic institutions, pharmaceutical industries, health care indust

determine when to bail out.

A 3-alarm blaze in Indy's downtown section, found three firefighters deep inside the bowels of the beast. A huge structure, the Athletic Club blaze was stubborn, and difficult to ventilate. According to other int

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

erior personnel, the trio entered a smoky room in search of the seat of the fire, but within moments the room erupted in an explosion of flame, instantly snuffing out their lives.

IFD was determined to prevent similar horrible accidents from

.

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

ever happening again. They imported the Swede Survival System, and since its installation, EVERY IFD firefighter and officer has received extensive flashover training. Many, more than once.

In other departments throughout the USA, training o

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

Companies that provide selfless information through particip

fficers have adapted the system to meet the needs of America's aggressive firefighters. Their goal, to show an uncontrolled blaze in a SAFE, controlled atmosphere. And to date, nearly fifty departments and agencies have answered the call.

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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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