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Imagine the difficulty of plowing a field with a team of oxen, or mules. The heat bores down, sweat streams off your brow, rocks hamper your progress, but still th

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

ere is work to be done and no one to lead the team except you. The life of our ancestors was simpler, but certainly more difficult.

When the farm tractor was inve

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

Examples of combination products may in

ted, it completely revolutionized agriculture, allowing millions of people to leave the farm and move into other areas of our economy; clearly it is an invention th

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

at changed the way we live, and respect should be shown to the inventor and also to the machine itself.

FACT: The first gasoline-powered tractor was made in 1892 b

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

John Froehlich, a blacksmith from Iowa. The very first mass-produced tractors were sold by C.W. Hart and C.H. Parr of Charles City, Iowa.

I did not grow up on a f

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

Combination pro

arm, but I did spend several weekends with my uncle who ran a working farm in Louisiana. I still remember waking up early (way too early) to milk the cows, then 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

tle down to a large breakfast, then chores of course. The first order of the day was making certain my uncle's tractor was in tip top shape.

He called her "Emma",

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

he never told me why, but he treated this lady of the farm with respect and admiration, only being one generation away from plowing the fields with a team of mules

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

he appreciated this tractor in a way few still can.

He crawled under the belly of the beast and explained to a young impressionable boy (me) that he was checking

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 differential (rear end to car enthusiasts), next came the hydraulic case, followed by the transmission. This was all done inside the barn, before 'ole Emma's e

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

gine was turned over. He explained in a slow southern drawl that any water inside would be close to the drain plugs and easy to remove (oil and water do not mix).

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

Following aspects would a

He reached up with a well worn crescent wrench, loosening the plugs one by one and checking that the fluid ran clear. Since this was not the first check of the se

dd to the challenges in developing combination products:

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

son, (just a quick check, mainly for my education) he had drained, flushed and filled the reservoir months before.

We moved onto the cooling system, making certain

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

there were no leaks and the antifreeze was topped off, ready to perform as designed. In the tool shed I'd noticed he kept several gallons of quality antifreeze in

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

reserve. Since it was spring during this check up, he used a 50/50 mix of antifreeze and water; giving efficient cooling, while still protecting us down to minus 2

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

5. We'd have other problems if that happened.

So far, so good, he grabbed a flashlight and checked the fans and pulleys, his weathered but experienced hands check

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng for wear, cracks or damage. Since these belts powered the water pump and cooling system, they'd need replacing at the first sign of wear. But like I said, this

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

check up was mainly for me, and his belts were well maintained, (though he had several on hand should the need arise).

We checked grease fittings, hose clamps and

.

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

the radiator, he knew 'ole Emma like the back of his hand and said... "Though she is an old lady, but hey, she still does the job better than most."

I learned more

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

Companies that provide selfless information through particip

than a bit of tractor maintenance that day, I learned to respect the land, the people who work it, and the equipment that makes their life just a little bit easier

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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