I Suggest - Home and Family

The night before a cold wind whistled through the cracks in the door, whiskery sounds of hard snow hit the window panes. Three days of blizzard conditions finally broke with the appearance of a brilli

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

ant sun in a crystal sky. The plows had been through and the country roads glistened with fresh packed snow. No salt or sand marred its surface, just four inches of glazed, ice-rink-hard white ice.

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

Examples of combination products may in

Perfect for sleigh riding.

One year apart, my brother and I couldn't wait to rescue our three man Radio Flyer sleigh from the rafters of the garage. A pumice stone quickly rid the runners of rust, ou

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

tongues sticking out in concentration. Three layers of flannel shirts, woolen sweaters were topped by wool plaid anorak jackets. Double gloves, some with holes, insured against frostbite, stubborn m

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

etal catches on galoshes firmly locked against the weather.

The previous summer we roamed the country roads on our bikes, ranging as far as six miles from home. A few miles to the north, our road sta

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

Combination pro

ted to climb. Hinting at the first Kittatinny mountain tucked in the northern corner of the state, the almost imperceptive rise in altitude gradually segued into a hill of considerable steepness, culm

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

inating in a dangerous cut at its peak. Locally known as four mile hill, it probably boasted a continuous rise for only two and one half miles. The exciting flip side of the coin was the promise of a

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

speedy fall from the heights on the downside of the hill. After lunch, no mention of this adventure passed our lips as we trudged our way alongside the road in the crunch verve. Unable to pass up ev

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

ery hill we saw on the way, our twelve year old bodies started to flag in strength.

Being brothers, there was of course some sibling rivalry. But our parents made a big deal out of sharing and taking

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

turns, the only way of keeping the squabbling down to a low roar. So we took turns steering, even pulling each other on the level stretches, counting the seconds in a sing-song voice. We would preten

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

d we were Indians, marking the trail for the way home with snowballs exploded on tree trunks. By now snow filtering down into our galoshes had turned our toes to cold granite, the pain slowly fading i

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

Following aspects would a

nto numbness. Indefatigable in our climb, we leaned into the hill, our sled whipping behind us, tugged relentlessly by gravity. Once we let go of the rope and had a panicky moment floundering down t

dd to the challenges in developing combination products:

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

e hill after it, ending in a heap at the bottom of a ravine. After that we were more careful. The final stretch loomed like a ski run in front of us. A setting sun turned the snow to orange, purple

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

clouds coming up from the west. Soon it would be dark, reminding us of dire warnings of what would happen to us if we stayed out too late.

Panting, we rested at the peak, standing on the sleigh for a

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

better view down the valley. No cars had passed us in the last half hour, so we felt safe in testing fate in the form of icy hill, gravity, and being late for supper. As soon as our breathy clouds d

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

iminished, we felt ready for the fast ride home. Suddenly, my brother flopped on the sleigh and pushing off down the hill with wind milling arms, quickly attained a speed of twenty miles per hour, dim

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

Professional from academic institutions, pharmaceutical industries, health care indust

nishing in the distance. Stunned, I stood there screaming his name, shouting "Stop!, stop!, wait, wait! Admitting defeat, I let out a weak 'wait'. Stuffing my scarf into my coat and fighting back te

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

ars, I slowly marched down the hill, slipping and falling in the dusk, the sharp ice ripping through my wet corduroy pants. I was tired, cold, hungry and lonely all at the same time. Added to that w

.

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

s the hate I felt for my brother for doing me this terrible trick. Imagining all kinds of punishment for staying out after dark, I planned my revenge in the form of sand in his shoes, itching powder i

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

Companies that provide selfless information through particip

n his sheets and a good punch in the jaw when I got back. Later, after the remonstrances from my worried parents, all I had strength for was a hot bath and supper by the fire. My brother just laughed

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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