Actual - Legal

Motorcycle accidents can kill and it is hardly surprising. As a motorbike rider you are 40 times more likely to be killed than car drivers or passengers. Y

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

ou are more likely to be killed on a motorbike than any other means of transport. In 2004 over 500 people were killed in road accidents and over 6000 were s

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

Examples of combination products may in

eriously injured. These are scary statistics but they are facts and need to be addressed seriously. Another important statistic is that 80% of motorcycle ac

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

cidents were caused by the negligence of another. Obviously motorcyclists are very vulnerable because of the lack of protection they have and the fact they

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

only have 2 wheels to keep the bike on the road. If a bikes crosses a man hole or some oil on the road it is a lot more difficult to keep control of a bike

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

Combination pro

than it is a car. Also the injuries you are likely to sustain will be a lot worse than a car accident.

So why are motorcycles so appealing to people when

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

they are so dangerous? Well unless you have driven a bike this can be hard to understand. Having driven motor bikes in my youth I can understand the thril

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

s. For me it was a case being a bit of a tom boy and not being old enough to drive a car and I needed transport to take me to work and back. It was only wh

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

en my second bike was stolen from my front garden that I decided to learn to drive a car and leave my biking days behind. The cold weather in winter was ano

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

ther factor which convinced me to learn to drive a car. But I will never forget the feeling of being astride a motorbike with just your clothing and helmet

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

as protection. There is nothing better to get the adrenalin going than riding a bike. To this day even though I have had a motorcycle accident I still woul

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

Following aspects would a

d like to get another bike if only for the summer.

To have an accident on a motorbike is quite a scary experience. Back in the late 90’s I was involved on

dd to the challenges in developing combination products:

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

the back of my boyfriends motorbike when a car came out at a junction and drove straight into us, obviously not seeing us at all. We were both thrown from t

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

he bike several feet. Luckily for us we were not traveling very fast and the injuries were not too serious. It could have been a lot worse as I was stupidl

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

wearing a short skirt. Normally I would have been wearing jeans and leathers but that night it was a warm summer evening and my boyfriend was giving me a l

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

ift just one way so I thought I would chance wearing a skirt! Big mistake! My arms and legs were badly scratched from the tarmac but I was lucky not to rec

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

Professional from academic institutions, pharmaceutical industries, health care indust

eive more severe injuries.

Our injuries may have been minor but the accident was not our fault and there was damage to the bike, our selves and the leather

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

coats we were wearing. Also once you have had an impact on your crash helmet you are supposed to replace it. With all this in mind we went to see a solicit

.

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 and started proceedings. The driver of the car admitted to not seeing us at all so it was a simple case and we won a substantial amount of compensation.

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

Companies that provide selfless information through particip

It took about 3 months but it was worth it as we replaced our crash helmets, fixed up the scratches to the bike and I bought some much need leather trousers

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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