Social Articles - Writing and Speaking

Having an e-Book replace my favorite dog-eared paperback is not something I want to think about. There is a certain sense of familiari

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

ty and comfort while reading a good paperback, sort of like hanging out with a good friend.

My trusty paperback can be carried in my

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

Examples of combination products may in

purse and pulled out when waiting in the doctor's office, and I can highlight favorite passages or doodle in the margins.

In addition

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

, the paperback is both affordable and recyclable. The multimedia, portable, content devices you need to read an e-Book start out at $

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

200. At those prices I can't afford to recycle.

It has been 12 years since e-Books have showed up online in places like AOL, before t

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

Combination pro

he dawn of the "world-wide-web". After a decade, e-Book sales are but a pimple on an elephant compared to printed book sales

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

. The Open e-Book Forum, a trade group for electronic publishers, states that sales at end of of 2005 were $11.8 million, a 41% jump f

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

rom the prior year. Even though book selling giant Barnes & Noble Inc. only grew their printed book business 4.7%, their sales at

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

year end (January 28, 2006) were $5.10 billion.

Before publishers make e-Books a staple of their marketing, digital rights management

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

technologies (DRM) need to be put into place. Publishers have legitimate concerns because thousands of books are being circulated wit

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

hout any compensation to the author or publishers.

With new technologies always developing, the growth of "electronic reading&qu

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

Following aspects would a

ot; online and the availability of portable multimedia content devices, e-books have the possibility of finally ‘taking-off"

dd to the challenges in developing combination products:

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

;. It's unlikely they'll ever replace printed books.

Personally, part of the joy of reading is holding a printed book, either hardcov

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

er or paperback, while propped up on a couple of fluffy pillows, covered with a warm blanket, during the cold months, or in a hammock,

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

dodging sunbeams during the summer months. Reading at the beach lends itself to paperbacks not e-books. I love to read when I go to t

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

he beach in between people watching and swimming.

I tried reading an e-book a friend wrote, in front of my computer. Believe me when

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

Professional from academic institutions, pharmaceutical industries, health care indust

I tell you I got fanny-fatigue while my eyes started to cross. I was told to make a copy of the e-book. HELLO! It would be cheaper to

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

buy a printed book from the standpoint of paper consumption and my time.

With new technologies always developing, the growth of "

.

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

;electronic reading" online and the availability of portable multimedia content devices, e-books have the possibility of finally

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

Companies that provide selfless information through particip

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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Owning your own small business is the new “American Dream”. The dream is this: that you can work less, have less stress, have more time for your family, have more money, take more vacations when you want, retire early, enjoy life more. What is the reality?

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