Top Articles - News and Society

So what's the problem and how do we fix it? Well here in America, our approach to firefighting has always been one of adopting an aggressive attack, a tactic that requires firefighting teams to make their way inside the

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

burning structure and remain there under even the most severe conditions.

Since the introduction of superior protective gear (Nomex and PBI) in the late 70’s, fire-training instructors nationwide have taught their stud

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

Examples of combination products may in

ents to conduct an extremely aggressive interior attack, sometimes referred to in the books as Offensive Strategy. The idea is to take an offensive stance, moving nozzles and hose lines deep inside a building to meet th

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

fire on its own turf. But my personal belief is that -- unless a life safety issue exists -- firefighters should never attempt to inhabit the same space as fire. Being there is a lot like snorkeling in shark-infested

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

waters, then poking a Great White in the eye.

According to a report issued by Captain William R. Mora of the San Antonio Fire Department, many firefighters (often Truck company members) choose to begin search and rescue

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

Combination pro

operations without the assistance of an Engine company and their hoseline. The obvious concern in these situations is that teams that have entered won’t have the extinguishing tools to cool a blaze should flashover rear

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

its ugly head. And with no hose (or lifeline rope) to follow back to safety, firefighters have no route out! When the search and rescue effort goes south, a firefighter can easily become disoriented and lost in the bl

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

ze. Without a buddy by his or her side, they face the unknown alone. Panic sets in and it’s just a matter of time before they breathe-out their bottle, collapse and succumb to the blaze.

“The root of the disorientation

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

problem in the fire service,’ the San Antonio study reads, ‘is the lack of knowledge about the extreme danger posed by enclosed structures and the disorientation sequence.”

In many communities, especially those protect

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

d by volunteer companies, firefighters sometimes ignore the important fact that fighting a structural blaze is a team effort. Rather than wait for next arriving units, short-staffed companies often begin search and resc

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

ue -- or the hoseline advance -- lacking appropriate support and resources.

Crucial to fire extinguishment is proper vertical ventilation, which we’ve all been taught should take place simultaneously with the hoseline a

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

Following aspects would a

ttack below. However, before the chain saw is on the roof, well-meaning hose teams – working alone -- may quickly find the seat of the fire and bravely open the nozzle to dampen the blaze. But with no vent opening to r

dd to the challenges in developing combination products:

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

lease smoke and hot gases, the team destroys the delicate thermal balance, allowing super-heated air from above to drop down to the floor and bake them like lobsters.

In cases like this, inexperienced firefighters may p

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

anic and abandon the line, leaving their partner behind. The team is now separated, company integrity is lost, and it can only go downhill from here. Call in the FAST team.

“Firefighters must be warned of the extreme

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

angers associated with enclosed structures,” says San Antonio’s Captain Mora. “(They) must be informed that (waging) an aggressive attack immediately on arrival may be ineffective and unsafe in many cases.”

There’s no

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

denying that firefighters must enter flaming structures to conduct search and rescue operations, especially when civilians are reported trapped, or the commanding officer feels that an interior attack is warranted. Howe

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

Professional from academic institutions, pharmaceutical industries, health care indust

er, changing the behavior of two generations of firefighters, who have had the term “aggressive interior attack” drilled into their helmets, will be a tough assignment for company officers and training personnel. Fortuna

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

tely though, some more forward thinking administrators have begun to embrace alternate tactics, like large line blitz attacks using portable master stream devices.

A reminder: We’re told that the most important tactic i

.

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

any type of firefight is size-up. So, the next time your company pulls up in front of a burning building, quickly establish command and learn as much about the situation at hand as you can. I f there is no life-safety

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

Companies that provide selfless information through particip

issue and no danger to surrounding structures, hold back the hoseteam, by their SCBA straps if you must. Wait for second due companies to arrive, then engage in a coordinated attack.

Like they say, "Everyone goes home!

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.toparticles.org.ua/article/187255/toparticles-Working-in-the-Dragons-Lair.html">Working in the Dragon's Lair</a>

BB link (for phorums):
[url=http://www.toparticles.org.ua/article/187255/toparticles-Working-in-the-Dragons-Lair.html]Working in the Dragon's Lair[/url]

Business and Marketing innovation is what drives a company's success – the more competitive the markets get, the more important it is for a business to show and employ creativity. The ultimate proof of Business and Marketing creativity comes under the form of creating breakthrough opportunities and competitive advantages: a Marketing mix that the target market sees as better than the competitor's mix. Among the most successful strategies to achieve a competitive advantage are those operating at market-level, especially market segmentation – the topic to be discussed within this article.

Can't afford to wait up to 60 days to get paid by your clients? Learn how invoice factoring can help you.

The US Trademark legislation developed from the nineteenth century when great growth of production and services demanded new regulation.

Tags

Links

Top Articles - Working in the Dragon's Lair

Related Articles: