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It’s cold out there! The cold air dries out the skin and burns the flesh of the most hearty winter lover. If you have a dog, you may have conside

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

red their comfort by providing a doggie coat. But what toll does the ice and snow take on their paws?

As a dog ages, he will become more suscept

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

Examples of combination products may in

ible to the elements. We found this out with our dog, Tikki a year or two ago. It was a bitter cold morning with a subzero temperature and unbeli

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

vable wind-chill. Tikki trotted off across our yard to do his business in private, as was his custom. A moment or two later, he sat down and rais

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

ed a front paw. We were used to seeing this behavior as he does this in the summer when he has a prickle stuck in his paw. He will sit down and w

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

Combination pro

ait until we come and take it out. But there were no thistles on the snow pack. A moment later, when he lifted his other paw we knew his feet wer

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

hurting from the extreme cold and coaxed him toward the house. Half way to the door, Tikki stopped and sat down and lifted all four paws in the

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

air, waiting for someone to carry him inside.

Tikki was raised in Minnesota and never exhibited this type of behavior in the cold before, but at

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

12 years of age, his feet couldn’t take it anymore. We now monitor the temperature before taking Tikki out. On extreme cold days, he isn’t allow

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

d to run and romp for as long as usual. He has frequent, but very quick, trips outdoors instead.

This experience did prompt us to research how t

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

o take care of our dog’s paws in the winter weather. Most discomfort is caused by one of two problems. Ice build-up and salt.

The ice builds up

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

Following aspects would a

in between the toes on your dog’s feet as they walk through the snow. The warm pads of your dog’s feet will warm the snow and cause it to melt. T

dd to the challenges in developing combination products:

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

is water refreezes in the fur between the toes and builds up into uncomfortable snowballs that would feel similar to a rock in your shoe. In Tikk

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

i’s case, it probably was similar to the prickles he gets in the summer.

To avoid this, limit your dog’s exposure to cold weather, trim excess h

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

air between the toes and consider all weather dog booties. There are many types and sizes of these boots. They are designed to be durable, comfor

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

able and easy to put on.

The other problem that can cause trouble for a senior dog’s paws in the winter is the exposures to chemicals and salt u

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

Professional from academic institutions, pharmaceutical industries, health care indust

sed to melt ice. Again the wet fur between the toes will trap the salt as your dog heads up to the front door. This salt or chemicals will become

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

irritating and dry the skin. Often the dog will try to chew or lick the paw causing further irritation as well as getting the chemicals into you

.

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

dog’s system.

The best remedy for this is to avoid the use of salt and chemicals where you take your dog in and out of your home. If this is no

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

Companies that provide selfless information through particip

t possible, rinse your dog’s paws after they have been exposed to salt and chemicals or try dog booties.

Copyright 2006 Dave Eckholm/Old Dog Paw

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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