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Motorcycling is perceived as an inherently dangerous activity, due to the high speed capabilities of the machines involved, and the relatively poor protection they o

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

ffer. There are approximately 28,000 accidents involving motorcycles annually in the United Kingdom, which goes to show just how vulnerable motorcyclists can be on t

; 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 road.

In order to try to prevent the rise of motorcycling accidents there are a number of things riders and fellow road users can do. For instance, it is importan

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

to make sure that bikers are wearing high visibility jackets or other appropriate clothing to ensure they can be seen by car drivers and other motorists. They shoul

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

take up a good road position, again where they are clearly visible to all of the other motorists using the road, to make sure they can be seen when going round corn

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

Combination pro

rs, or when overtaking. The main problem for motorcyclists is that they are obviously driving vehicles that are much smaller than normal cars, and therefore are hard

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

r to spot, especially when looking through mirrors. Of course, it doesn’t help that many car drivers can be ignorant when they are on the road, and don’t bother to e

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

ven look for passing motorcyclists when manoeuvring. There have been recent hard hitting government advertising campaigns designed to highlight the dangers faced by

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

otorcyclists on the roads, particularly other motorist’s inability to spot them before turning corners, and passing through junctions.

Accidents involving motorcycl

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

sts can be devastating, as they do not have the protection a car offers. It is therefore essential to make sure that each time you go out on your bike you are wearin

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

the advised protective clothing, such as leather pants, jacket and gloves, and preferably some form of high visibility outerwear. The helmet is probably the most im

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

Following aspects would a

ortant feature of a motorcyclist, and is required to be worn at all times when on a bike by law. Having a helmet in is probably the single most valuable weapon for p

dd to the challenges in developing combination products:

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

eventing fatalities in accidents involving motorcyclists; don’t wear one, and the risk of being killed in an accident rises by 40 per cent. Riders not only need to g

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

t themselves ready for the road, but the actual bikes they use need a large amount of preparation and maintenance as well. Even the tyres need careful consideration,

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

such as size, type and pressure, which can all have an effect depending on the type of roads being ridden on. Finally, it is just as dangerous to be under the influ

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

nce of drugs or alcohol when riding a motorcycle as it is in a car, and motorcyclists have more chance of involved in an accident when drunk or on drugs.

It is impo

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

Professional from academic institutions, pharmaceutical industries, health care indust

tant for motorcyclists to make sure they report any accidents, however small, to their insurance companies and the police. Conditions can only be changed and improve

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

if the people who can help are aware of the pitfalls and dangers that motorcyclists face, even down to such things as poor road maintenance, which is a big contribu

.

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

or to motorcycling accidents. It is each person’s legal and civil right to make a claim; despite the fact that public perception sees the motorcyclist as the reckles

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

Companies that provide selfless information through particip

driver, it is more often than not other road users at fault for accidents, and this needs to be highlighted in order for accidents involving motorcyclists to be cut

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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