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If you're over 40, you probably remember a time when there was no such thing as the internet, cable TV, or even fax mach

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

ines. But now that our everyday lives depend on these things and other high tech devices, it's difficult to imagine how

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

Examples of combination products may in

we ever managed without them. Many of us are so addicted to our cell phones and blackberries that we go through withdra

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

al if we accidentally leave home without them. Wrist watches are a dying breed since all of our electronic devices have

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

digital clocks, and kids can't even tell time anymore on a conventional clock. Let's not even discuss Roman numerals.

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

Combination pro

aybe it's time to get back to nature - back to human nature and mother nature. We have become robots - slaves to techno

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

logy. What ever happened to going on vacation simply to relax? Even when we go camping we choose campgrounds with high

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

speed internet and cable hook-ups. What would happen if we spent a week without our cell phones, blackberries, laptops

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

nd cable TV? Would we know what to do with ourselves? Would we actually have to hold meaningful conversations with oth

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

r members of our families?

De-teching yourself is like detoxing. It might be difficult at first, but the benefits are w

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

rth the effort. Obviously some good can come out of having electronic devices in the middle of nowhere, like cell phone

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

Following aspects would a

s for emergency purposes and GPS devices to help you find your way. But vacations should be times when you can do thing

dd to the challenges in developing combination products:

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

you normally don't do at home. Learn how to build a campfire. Stop and smell some flowers. Look at the birds. Colle

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

t some rocks. Fish. Hike. Row.

Too often we vacation at places that offer so much to do under one roof. What's wron

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

with that? Nothing really. After all, many of us have jobs that don't allow us much time off, so we feel the need to

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

ack as much activity into one week (or weekend) as we possibly can. And we have to keep the kids busy and happy, right?

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

Professional from academic institutions, pharmaceutical industries, health care indust

How is that possible without video games? Well, you would probably be surprised at how long your kids can keep themse

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

ves busy when they have the great outdoors and only rocks and sticks to play with. You probably just never knew this be

.

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

ause they are hooked up to their electronic devices 24/7 at home.

De-tech yourself. Get back to nature. Get back to b

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

Companies that provide selfless information through particip

ing human. What have you got to lose? Stress? Maybe you'll even find something you've already lost - like your sanity

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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