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Fleet Owners
Small businesses are losing thousands of dollars every year from employees drivin

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

g company vehicles. Employees running personal errands in company vehicles, speeding, not on the

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

Examples of combination products may in

ob site when they should be. Are your employees at the job site or at home taking an extended lunc

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

? Do you know with absolute certainty where your company vehicle is? Do they drive your vehicle a

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

though it is an important asset?

Effect on Engine:
Careful analysis of the road experience i

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

Combination pro

dicates the ideal speed for the average truck is 50-55mph, the power required to increase speed mul

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

iplies dramatically:
• 73% more horsepower to cruise at 60mph
• 159% more horsepower to c

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

uise at 70mph

Effect on Fuel Cost:
Research indicated that each mile per hour above 50 mp

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

increases fuel consumption by 1 1/2 percent. A truck, which averages 8 mpg at 50 mph, will average

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

6.8 mpg at 60 mph.

Effect on Tires:
Heat is the number one enemy of tires. Sustained speeds r

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

ise tire temperatures above the critical level causing strength and wear properties to deteriorate

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

Following aspects would a

rapidly. Tire wear will almost double at road speeds of 70 mph or greater.

Effect on Maintenance C

dd to the challenges in developing combination products:

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

st:
Gears, bearings, clutches, suspension and drive trains all wear much faster at higher spee

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

s. Increasing speed from 50 mph to 60 mph increases maintenance cost by 38%. Increasing the speed t

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

70 mph increases the cost by 80%.

Effect on Idling:
Idling causes twice as much damage as dr

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

ving. One hour's idling is equivalent to between 80 and 120 minutes of driving time. The resulting

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

Professional from academic institutions, pharmaceutical industries, health care indust

oss of fuel economy from excessive idling can add up to 800 gallons of fuel annually for the averag

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

truck.

Effect on Accidents:
Approximate stopping distances, including reaction time for the

.

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

verage person (2 axle trucks) are listed below:
• @ 50 mph - 275 feet (.92 football fields)

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

Companies that provide selfless information through particip

• @ 60 mph - 375 feet (1.25 football fields)
• @ 70 mph - 500 feet (1.67 football fields)

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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