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It is very visible on the busy roads of California that motorcycles share only a small fraction of the total number of vehicles. But, how come that 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

studies showed that motorcycle accidents were attributed for the ten percent of all the casualties which resulted from a variety of vehicle tragedies? W

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

Examples of combination products may in

hat are the reasons why riding these bikes is presumed risky? How, then, may the riders prevent themselves from being involved in a catastrophic motorcy

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

cle accident? Whether you are a motorcycle enthusiast or not, knowing the answers to these questions should matter to you before you see yourself a vict

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

im of these “killer-two-wheelers.”

Motorcycle riding is quite risky for an individual. Just imagine yourself on a bike and between those speeding cars,

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

Combination pro

trucks and buses. Would you be at ease or comfortable knowing that you are in the middle of life and death situation? Even for a fact that most of the

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

motorcycle-automobile collisions are due to the motorcycle drivers’ fault, still, they have the stronger tendency to be thrown away and suffer severe in

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

uries or even die. This is very much true because of these bikes structural design wherein it has neither a metal cage nor a seatbelt to protect the rid

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

ers in case of accidents. Riding these motorcycles is indeed comparable to making your own coffin.

More so, the sizes of these bikes may contribute to

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

the dangers which come along in riding it, especially in night travel wherein most drivers of larger vehicles unnoticeably run over or block these two-w

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

heeler’s path causing it to slide and collide to any other object along the area of the accident. Another reason is when the undisciplined motorcycle ri

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

Following aspects would a

ders disregard the traffic controls and warnings. The most common of these scenarios happen in road intersections, wherein some unruly bikers attempt to

dd to the challenges in developing combination products:

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

beat the red light which result traffic disasters. Having a shot in passing another vehicle on an inappropriate part of the road or on a curved area ma

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

y also be a root of an accident. Doing this is undeniably dangerous because the driver of the approaching vehicle on the other side may not have a clear

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

view of you and it may become too late before he notice you and step on his break.

Majority of these reasons are beyond the control of the motorcycle d

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

rivers. However, it is still possible to at least minimize the risk of being involved in these road misfortunes by abiding the traffic rules, having a w

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

Professional from academic institutions, pharmaceutical industries, health care indust

atchful eye and doing a regular check on your bikes. Also wearing safety gears may help in reducing the possibility of fatal injuries.

On the other sid

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

e of this matter, the victims of these terrible incidents may result in filing their cases in order to uphold their rights and obtain whatever amount of

.

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

damages as prescribed by the law. And in pursuing a claim case, it is very much advisable to seek the assistance of a credible motorcycle accident lawy

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

Companies that provide selfless information through particip

er who has the expertise in handling these certain cases. A worthy legal counsel to guide and defend these victims will ensure them of acquiring justice

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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