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The United States remain largely popular as a country of cars. No one person can ever go a few miles without his or her trusted car. However, because of the gasoline prices plus the fun of riding through the open road, moto

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

rcycles have steadily gained popularity.

Motorcycles zooming along the road are now among the common sights in any United States highway. Last 2004, sales of new motorcycles have gone beyond one million dollars. This figur

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

Examples of combination products may in

e increased higher by the summer of 2005 and yet gained another high by the year of 2006 especially since fuel prices have reached their all time high prices. State laws all over United States have the same definition of t

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 motorcycle. Accordingly, motorcycle as a motor vehicle with a seat or saddle for the rider and have no more than three wheels. In some states, though, they have included the mopeds, while others do not.

Terrain vehicles

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

or motorized bikes, which are off-the-road vehicles, are not included in the definition of the motorcycle. Thus, there are different laws and regulations for these vehicles. Having significant knowledge of the state laws go

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

Combination pro

erning the vehicle you aim to drive is important. Due to the high-speed capability of motorcycles, and the minimal protection it gives its occupant, it became known as the most dangerous vehicle ever to grace the highway.

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

According to studies, motorcycles topped all other vehicles for crash cost per person per mile. Fatalities caused by motorcycle-related accidents in the highways and streets increased by more than 40 percent since 1997. Co

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

nsequently, there is also a rise on the number of injuries acquired from such accidents.

Collected data on motorcycle-related accidents have the following findings:
- there are very rare cases of vehicle defects

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

most victims of such accidents are male, between the ages of 15 and 24
- Three fourths of the accident cases implicate collision with another vehicle, and most of these are passenger automobiles. While one fourth invo

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

lves the collision of the motorcycle with some other object, a single vehicle accident.
- These collision accidents are mostly due to lack of attention on the part of the rider and a notable lack of training
- Ma

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

y motorcyclists have no license or have revoked license.
- Driving under the influence of alcohol or DUI cases
- Only minimal cases involve accidents due to bad weather, road defects and animal involvement

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

Following aspects would a

- Most cases also involve speeding

Injuries acquired from motorcycle – related accidents are usually covered by private health insurance coverage, which benefits only a little more than half of crash victims. The gover

dd to the challenges in developing combination products:

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

nment actually covers most of the medical costs in such cases. Other victims get to be covered by the Medicaid program or some other government program. Like car accident victims, motorcycle accident victims also face loss

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

f work and loss of wage for work missed during hospitalization or due to the permanent disability after the accident. This finally results to decreased quality of life. These serious implications of motorcycle-related acc

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

idents lead to the promulgation of the 2006 Motorcycle Safety Program Plan by the National Highway Traffic Safety Administration (NHTSA). As an upgrade of their 2003 Plan, the 2006 Plan have the recommendations for implemen

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

ation by state and local governments as preventive measures against motorcycle related accidents.
- increase access of riders to rider education programs
- increase the number of properly licensed motorcyclists<

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

Professional from academic institutions, pharmaceutical industries, health care indust

br> - reduce the cases of motorcyclists riding while sill impaired
- increase visibility of motorcyclists in roads, especially highways
- increase the use of helmet as ultimate protective gear
- Increase th

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

e awareness of other motorists’ on the presence of motorcyclists alongside them in highway roads.

Aside from helmets, as protective gear, motorcyclists must also wear proper reflective clothing, complete with gloves, b

.

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

ots, long pants and a long sleeved jacket. There must also be adequate eye and face protection for the motorcycle riders.

Furthermore, as an added safety net if ever accidents happen, all of the states, except for Washingt

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

Companies that provide selfless information through particip

on required motorcycle riders to avail of minimal comprehensive insurance coverage, at the very least. Moreover, other states have certain laws that require a motorcycle owner and driver to manifest financial responsibility

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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