Social Space - Automotive

Bill started backing the car down the driveway on your way to church. You noticed

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

something, liquid, on the driveway.

You made him stop the car, and then you two

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

Examples of combination products may in

ot out and walked up the driveway to where the 'green stuff' was.

“What is that g

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

reen stuff on the driveway, and where is it coming from?” you ask.

You have coola

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

t leaking from your car.

Sometimes a water hose will create a hole and cause cool

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

Combination pro

ant to leak out.

Sometimes a hose clamp will lose its strength and let coolant se

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

p past.

Sometimes a thermostat or water pump gasket will leak.

There are several

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

places, or parts, which can go bad and let coolant get by.

Today we will look at

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

coolant leaking from the front of the engine.

It looks as though it's coming from

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 water pump, but it could be the lower radiator hose, or clamp.

Take a small

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

irror and hold it under the water pump, if you can get to it.

There is a small ho

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

Following aspects would a

le on the bottom of the water pump…it's called a *weep* hole.

Actually it is a ho

dd to the challenges in developing combination products:

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

e in the casting of the water pump to let coolant escape when the seal inside the

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

water pump deteriorates.

Coolant leaks from this little hole to let you know that

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

the seal has gone bad.

Without coolant leaking here, you would not know that the

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

seal has gone out and coolant would get to the bearing on the pump shaft and ruin

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

Professional from academic institutions, pharmaceutical industries, health care indust

he bearing.

If the bearing gets coolant inside, it will destroy the grease and ca

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

use the ball-bearings to run hot...metal-to-metal. Not good.

Then the pump shaft

.

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

will break-off and cause a whole lot of trouble...like the fan going into the radi

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

Companies that provide selfless information through particip

ator...unless you have an electric fan.

Aren't you glad that little hole is there

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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