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Ever since I was a kid, I have always loved roller coasters and other scary type rides. The scariest I have ever been on are not even in an amusement park. The scariest rides are in Las Vegas at the top of the S

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

tratosphere! There are currently four rides in the top of this 1,149 foot tall tower, though the rides are mostly between the 900 and 1,000 foot levels. I have not been there since they competed the fourth ride.

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

Examples of combination products may in

I will describe the rides in the suggested order of riding.

The first ride is a little roller coaster named High Roller. On the ground this would be a little kiddie roller coaster. But when you are rolling arou

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

nd the tracks over 900 feet up in the air, it is a little different. While not really really scary it is a bit unnerving.

The next ride is called The Big Shot. I have been of rides similar to this one, but none

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

have nearly the impact of this one. This ride is on the needle at the top of the tower. The needle has three sides, and there are a row of seats on each side. You are strapped into the seat securely with your ba

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

Combination pro

k to the needle. There is a wait period, then you will be slowly lift off the ground to about 10 feet in the air. Still no big deal. Then without warning, you are ROCKETED upward. As you go up, you don't see 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

tower anymore. You only see out, and that you are around a 1,000 feet in the air. There is a weightless feeling as through you have come disconnected from the tower. I screamed the first time I felt this. Unlik

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

other rides like this that I have been on, you don't feel when you hit the top, and start falling. For example the similar type ride in California Adventureland, you actually feel a bit of braking toward the to

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

. You do not feel this braking on the Big Shot. You will start free falling down again. Then the seat will bungee up and down until you are finally lowered at the end of the ride.

The third ride is the scariest

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

of the three. It is called X-Scream. This ride is like a open side bobsled mounted on a see-saw. The first time I rode this, I was in the second row. You are strapped securely into the bobsled part. The teeter-

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

otter will start to tip up, and the bobsled will slide to the other end of the track. Ummm...did I mention other end of the track is over 30 feet out over the edge of the tower? So then you are sliding forward d

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

Following aspects would a

wn the track toward the over 900 foot drop straight down to sin city! Then the track will tilt back, and you will slide backwards. Then it will tilt forward again, and you will get to the end of the track. The c

dd to the challenges in developing combination products:

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

ar might creep a little forward, and then drop some more. The track might lift, and then drop again. The ride has some different programs so that the slides and falls are not predictable to the rider. At the end

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

of the ride, the guys in the front row said that for the full effect, you need to be in the front row. This is true. IF YOU WANT THE SCARIEST EXPERIENCE, RIDE IN THE FRONT ROW, EVEN IF YOU HAVE TO WAIT! I rode t

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

e ride again, this time in the front row. They were absolutely right! In the front row, you have nothing between you and ground 900 feet below except a bar, and a harness. You start thinking what if some bolt or

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

cable breaks!

I had bought a ticket to ride all of the rides as many times as I wanted. I ended up riding the High Roller coaster once, the Big Shot once, and the X-Scream twice. That was enough. My legs were

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

Professional from academic institutions, pharmaceutical industries, health care indust

haking! I had had enough for the day. I did ride these rides again on my next visit to Las Vegas when my brother was there. I kept thinking to myself why am I on these rides again?

The newest ride is called In

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

anity The Ride. Looking at the Stratosphere's website, I don't see the High Roller listed anymore. They may have removed it for this ride. From reading, and looking at the photos, it appears that the Insanity ri

.

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

de has 5 arms that hang down form a wheel attached to a big arm, with each small arm having two seats at the bottom. You are strapped into the seats, and then the big arm swings you out over the edge. Then the w

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

Companies that provide selfless information through particip

eel starts to turn and the hanging arms swing outward with you strapped to them. It would probably be very scary, but I have not ridden it yet.

If you get to Las Vegas, and like scary rides, you gotta try these

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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Healthcare and health insurance costs continue to increase at a dramatic rate. As consumers, we have the ability to make lifestyle choices that will not only reduce our healthcare costs but improve our quality of life.

More and more people think about starting their home-based-business. However, only a small percentage really succeed in making a decent income from these activities. Do you really have to be an expert in order to be successful?

It is suspected that a school is operated at the White House to train its executives in the difficult art of providing non-answers.

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