References - Automotive

I would like to share with you some of the daily safety problems that the professional truck driver faces. In my opinion, cars maneuvered by poor drivers (J. Q. Public

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

) must have a magnet installed in their front bumper that attracts them to trucks. This magnet pulls them within thirty feet of the rear of semi-trailers.

The semi dr

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

Examples of combination products may in

iver CAN NOT see anything behind the trailer within that distance. This magnet theory is the only reasonable explanation for auto drivers following too closely behind

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

semi trailers.

Cars not equipped with this magnet are operated by good drivers who keep the 2 to 4 second rule for following distance (about 100' to 250') behind a tr

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

ck. J. Q. Public, with his magnet engaged, pulls out in the passing lane, gets even with the truck, and sets up residency.

If J. Q. Public were a good driver, he wou

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

Combination pro

ld move from behind the truck, pass quickly and safely, and allow adequate space after the maneuver. He would watch his inside rearview mirror and make sure both of th

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

e truck's headlights were visible in the mirror as he merged back to the right.

Another example of the magnet theory occurs when making a right hand turn. While Mr. T

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

uck Driver pays close attention to the right mirror on the cab of the truck and watches the left corner of the truck, the magnet activates and J. Q. Public sneaks alon

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

g side to get around the corner before the truck does. The car is hit by the tandem on the trailer.

The truck needs all this space (approximately 120') to complete th

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

e turn safely. Having arrived at his destination, typically Mr. Truck Driver will need to back into a loading dock. It would appear that sometimes he is expected to be

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

d into places even a helicopter could not land.

Back on the interstate, Mr. Truck Driver knows that in 5 to 10 miles there will be a weigh station. As a professional,

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

Following aspects would a

the driver puts on his RIGHT-TURN SIGNAL to make his way over to the right lane to exit off. Remember the magnet theory.

The cars instantaneously get closer to each

dd to the challenges in developing combination products:

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

other. The weigh station that was 5 to 10 miles ahead is now 3 miles closer. A good driver would slow down and let the truck merge into the right lane.

1. Do not tail

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

gate. Remember the 2 to 4 second rule, 100' to 250'.

2. Wait your turn at an intersection. When you see a truck turning or backing up, give him a break, remember the

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

0' rule.

3. Pass a truck and allow plenty of room to merge back. Remember both truck headlights in should appear in your rearview mirror.

4. Remember trucks use sign

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

als so a blinking signal means we are going to turn. We are not thinking about turning. We are definitely going to turn in the direction of the blinking light. So don'

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

Professional from academic institutions, pharmaceutical industries, health care indust

t cut us off, especially right turns.

5. Plan ahead when you see slow moving vehicles. Trucks, U-Hauls, campers, and some truck lines still have their speed at 55 to

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

7 mph.

6. PLEASE let us over, the sign says "Weigh Station 1 Mile".

7. Leave yourself an out. Don't be so close to the vehicle ahead of you that if something happens

.

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

you have a wreck. Never ever get yourself boxed in: always leave room to escape.

If people could ride with a truck driver for a week, they would soon understand. My

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

Companies that provide selfless information through particip

door is open to anyone who thinks my job is easy. I am inviting them to ride along, watch, learn, get a better understanding because without trucks, America would stop

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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References - Defensive Driving with Trucks - 7 Tips From a Trucker that Could Save Your Life

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