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Drinking alcohol and driving a car is a deadly combination.

The danger is clear:

In the United States, someone is killed in an alcohol-related motor vehicle crash every 30 minutes.

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

Four out of every ten fatal car accidents involve alcohol, according to the National Highway Traffic Administration.

Nearly 17,000 Americans died in alcohol-related automobile crashes

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

Examples of combination products may in

in 2004. The Dangerous Effects of Alcohol on Automobile Drivers

The fact is that anyone who has been drinking should not get behind the wheel of a car. Driving a car

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

requires concentration, coordination, ability to judge distance and speed, common sense, and a concern for the safety of everyone on the road. Alcohol can impair these basic skills that are neces

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

ary to operate an automobile safely.

Every type of alcohol affects a persons ability to drive a car. The same amount of alcohol - and the same potential for impairment or intoxication - results

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

Combination pro

rom any of these drinks:

12 ounce can of beer
5 ounce glass of wine
1.5 ounce shot of whiskey.

Some people mistakenly believe that coffee, a cold shower, exerc

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

se, or fresh air can sober them up. This is not true. The only thing that sobers you up is time.

The Risks of Driving a Car While Using Drugs

Drugs and medications can be as da

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

gerous as alcohol when mixed with driving. Illegal drugs are particularly risky, because users cannot be sure of the contents, purity, or possible effects of these substances. Prescriptions and

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

over-the-counter medicines can also hurt your ability to drive safely. Some cold remedies, allergy medicines, tranquilizers, and pain relievers may cause drowsiness. Diet pills and "stay awake"

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

rugs may cause excitability or drowsiness.

Individuals have different reactions to the same drug, depending on physical condition. Combinations of drugs, or drugs with alcohol, can have unexpect

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

d effects.

Protect Yourself and Others from Drunk Driving Accidents

Never drink and drive an automobile.

If you plan on drinking, select a designated driver ahead of time who

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

Following aspects would a

is not going to drink. Otherwise, ask someone for a ride, call a taxi, take a bus, or seek other assistance. In short, do whatever you need to do to avoid getting behind the wheel of a car if you

dd to the challenges in developing combination products:

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

driving may be impaired by alcohol or drugs.

Be a good friend, if someone you know has been drinking or using drugs. Do not let him or her try to operate an automobile. If necessary, take away

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

he person's car keys. Help your friend find a safe ride home or a place to sleep.

Never ride with anyone who has been drinking or using drugs. Be sure a driver is completely sober before you get

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

into the car.

Recognizing Drunk Drivers on the Highway

At times, it is possible to recognize drivers who may have been drinking or using drugs. Stay alert, and watch for signs

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

f a drunk driver. They may:

Weave within the traffic lane.
Wander from one lane to another.
Run off the pavement.
Stop too quickly or slowly.
Drive too q

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

Professional from academic institutions, pharmaceutical industries, health care indust

ickly or slowly.

Go through stop signs or other signals.

Drive on the wrong side of the road.

These signs do not always mean that the driver of the car is intoxicated,

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

ut they do require your full attention. When you are on the road near a potential drunk driver, put as much distance as possible between your car and that person's vehicle. If you are behind 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

vehicle, think twice about trying to pass. If you are ahead of that car, leave space for the drunk driver to pass you. Stay alert, because you may encounter the same car further down the road.

I

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

Companies that provide selfless information through particip

possible, report the dangerous situation to the police. Call 911 and give the emergency operator a description and license plate number of the drunk driver's car, and the location of the vehicle

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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